Drugs@FDA: FDA-Approved Drugs

Recent New and Generic Drug Approvals

This report displays final approvals and tentative approvals of original and supplemental applications for the two weeks beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this timespan. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.

• 7 Day Report
• 14 Day Report

May 2, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Esmolol Hydrochloride Double Strength In Plastic Container NDA #205703	Esmolol Hydrochloride	Solution; Intravenous	SUPPL-3	Hq Spclt Pharma	Labeling	Approved
Esmolol Hydrochloride In Plastic Container NDA #205703	Esmolol Hydrochloride	Solution; Intravenous	SUPPL-3	Hq Spclt Pharma	Labeling	Approved

May 1, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Amoxicillin ANDA #061926	Amoxicillin	Capsule; Oral	SUPPL-136	Teva	Labeling	Approved
Amoxicillin ANDA #061931	Amoxicillin	For Suspension; Oral	SUPPL-60	Teva	Labeling	Approved
Amoxicillin ANDA #062058	Amoxicillin	Capsule; Oral	SUPPL-15	Chartwell	Labeling	Approved
Amoxicillin ANDA #062059	Amoxicillin	For Suspension; Oral	SUPPL-6	Chartwell Rx	Labeling	Approved
Amoxicillin ANDA #062881	Amoxicillin	Capsule; Oral	SUPPL-29	Strides Pharma	Labeling	Approved
Amoxicillin ANDA #062884	Amoxicillin	Capsule; Oral	SUPPL-26	Strides Pharma	Labeling	Approved
Amoxicillin ANDA #062927	Amoxicillin	For Suspension; Oral	SUPPL-29	Dava Pharms Inc	Labeling	Approved
Amoxicillin ANDA #064013	Amoxicillin	Tablet, Chewable; Oral	SUPPL-64	Teva	Labeling	Approved
Amoxicillin ANDA #064076	Amoxicillin	Capsule; Oral	SUPPL-38	Sandoz	Labeling	Approved
Amoxicillin ANDA #064139	Amoxicillin	Tablet, Chewable; Oral	SUPPL-16	Chartwell Rx	Labeling	Approved
Amoxicillin ANDA #065056	Amoxicillin	Tablet; Oral	SUPPL-26	Teva	Labeling	Approved
Amoxicillin ANDA #065119	Amoxicillin	For Suspension; Oral	SUPPL-33	Teva	Labeling	Approved
Amoxicillin ANDA #065228	Amoxicillin	Tablet; Oral	SUPPL-20	Sandoz	Labeling	Approved
Amoxicillin ANDA #065255	Amoxicillin	Tablet; Oral	SUPPL-28	Hikma	Labeling	Approved
Amoxicillin ANDA #065256	Amoxicillin	Tablet; Oral	SUPPL-25	Aurobindo	Labeling	Approved
Amoxicillin ANDA #065271	Amoxicillin	Capsule; Oral	SUPPL-25	Aurobindo	Labeling	Approved
Amoxicillin ANDA #065291	Amoxicillin	Capsule; Oral	SUPPL-33	Hikma Pharms	Labeling	Approved
Amoxicillin ANDA #065322	Amoxicillin	For Suspension; Oral	SUPPL-39	Hikma	Labeling	Approved
Amoxicillin ANDA #065325	Amoxicillin	For Suspension; Oral	SUPPL-35	Hikma	Labeling	Approved
Amoxicillin ANDA #065334	Amoxicillin	For Suspension; Oral	SUPPL-25	Aurobindo	Labeling	Approved
Amoxicillin ANDA #065344	Amoxicillin	Tablet; Oral	SUPPL-8	Chartwell Rx	Labeling	Approved
Amoxicillin ANDA #065378	Amoxicillin	For Suspension; Oral	SUPPL-19	Sandoz	Labeling	Approved
Amoxicillin ANDA #065387	Amoxicillin	For Suspension; Oral	SUPPL-19	Sandoz	Labeling	Approved
Amoxicillin ANDA #204030	Amoxicillin	For Suspension; Oral	SUPPL-13	Aurobindo Pharma Ltd	Labeling	Approved
Amoxicillin ANDA #207471	Amoxicillin	Capsule; Oral	SUPPL-2	Micro Labs	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065063	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-51	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065064	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-50	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065065	Amoxicillin; Clavulanate Potassium	Tablet, Chewable; Oral	SUPPL-35	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065066	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-50	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065089	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-30	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065093	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-33	Sandoz Inc	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065096	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-39	Teva Pharms Usa	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065096	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-39	Teva Pharms Usa	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065098	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-25	Sandoz Inc	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065101	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-38	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065117	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-34	Sandoz Inc	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065162	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-40	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065162	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-40	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065189	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-30	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065191	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-35	Hikma Pharms	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065205	Amoxicillin; Clavulanate Potassium	Tablet, Chewable; Oral	SUPPL-30	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065317	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-4	Apotex Inc	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065317	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-4	Apotex Inc	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065333	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-4	Apotex Inc	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065333	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-4	Apotex Inc	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065373	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-27	Hikma Pharms	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065373	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-23	Hikma Pharms	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065373	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-27	Hikma Pharms	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065373	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-30	Hikma Pharms	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #090227	Amoxicillin; Clavulanate Potassium	Tablet, Extended Release; Oral	SUPPL-19	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #201090	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-14	Aurobindo Pharma Ltd	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #201091	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-13	Aurobindo Pharma Ltd	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #204755	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-12	Micro Labs Ltd India	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #205187	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-4	Micro Labs Ltd India	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #205707	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-12	Micro Labs Ltd India	Labeling	Approved
Amoxicillin Pediatric ANDA #061931	Amoxicillin	For Suspension; Oral	SUPPL-60	Teva	Labeling	Approved
Amoxil NDA #050542	Amoxicillin	Tablet, Chewable; Oral	SUPPL-32	Us Antibiotics	Labeling	Approved
Amoxil NDA #050754	Amoxicillin	Tablet; Oral	SUPPL-22	Us Antibiotics	Labeling	Approved
Amoxil NDA #050760	Amoxicillin	For Suspension; Oral	SUPPL-23	Us Antibiotics	Labeling	Approved
Amoxil NDA #050761	Amoxicillin	Tablet, Chewable; Oral	SUPPL-19	Us Antibiotics	Labeling	Approved
Amoxil ANDA #062216	Amoxicillin	Capsule; Oral	SUPPL-44	Us Antibiotics	Labeling	Approved
Amoxil ANDA #062216	Amoxicillin	Capsule; Oral	SUPPL-44	Us Antibiotics	Labeling	Approved
Amoxil ANDA #062226	Amoxicillin	For Suspension; Oral	SUPPL-40	Us Antibiotics	Labeling	Approved
Ampicillin Sodium ANDA #061395	Ampicillin Sodium	Injectable; Injection	SUPPL-52	Sandoz	Labeling	Approved
Ampicillin Sodium ANDA #062692	Ampicillin Sodium	Injectable; Injection	SUPPL-2	Hikma	Labeling	Approved
Ampicillin Sodium ANDA #062719	Ampicillin Sodium	Injectable; Injection	SUPPL-16	Istituto Bio Ita Spa	Labeling	Approved
Ampicillin Sodium ANDA #062738	Ampicillin Sodium	Powder; Intravenous	SUPPL-33	Sandoz	Labeling	Approved
Ampicillin Sodium ANDA #062772	Ampicillin Sodium	Injectable; Injection	SUPPL-17	Hq Speclt Pharma	Labeling	Approved
Ampicillin Sodium ANDA #062797	Ampicillin Sodium	Injectable; Injection	SUPPL-13	Istituto Bio Ita Spa	Labeling	Approved
Ampicillin Sodium ANDA #063142	Ampicillin Sodium	Injectable; Injection	SUPPL-18	Hq Speclt Pharma	Labeling	Approved
Ampicillin Sodium ANDA #065493	Ampicillin Sodium	Injectable; Injection	SUPPL-11	Eugia Pharma Speclts	Labeling	Approved
Ampicillin Sodium ANDA #065499	Ampicillin Sodium	Injectable; Injection	SUPPL-13	Eugia Pharma Speclts	Labeling	Approved
Ampicillin Sodium ANDA #090354	Ampicillin Sodium	Injectable; Injection	SUPPL-7	Antibiotice	Labeling	Approved
Ampicillin Sodium ANDA #090581	Ampicillin Sodium	Injectable; Injection	SUPPL-5	Sagent Pharms Inc	Labeling	Approved
Ampicillin Sodium ANDA #090583	Ampicillin Sodium	Injectable; Injection	SUPPL-5	Sagent Pharms Inc	Labeling	Approved
Ampicillin Sodium ANDA #090884	Ampicillin Sodium	Injectable; Injection	SUPPL-3	Acs Dobfar Spa	Labeling	Approved
Ampicillin Sodium ANDA #090889	Ampicillin Sodium	Injectable; Injection	SUPPL-3	Acs Dobfar Spa	Labeling	Approved
Ampicillin Sodium ANDA #201025	Ampicillin Sodium	Injectable; Injection	SUPPL-10	Steriscience	Labeling	Approved
Ampicillin Sodium ANDA #201404	Ampicillin Sodium	Injectable; Injection	SUPPL-8	Istituto Bio Ita Spa	Labeling	Approved
Ampicillin Sodium ANDA #202198	Ampicillin Sodium	Injectable; Injection	SUPPL-7	Steriscience	Labeling	Approved
Ampicillin Trihydrate ANDA #061502	Ampicillin/Ampicillin Trihydrate	Capsule; Oral	SUPPL-140	Chartwell Rx	Labeling	Approved
Ampicillin Trihydrate ANDA #062882	Ampicillin/Ampicillin Trihydrate	Capsule; Oral	SUPPL-17	Strides Pharma	Labeling	Approved
Ampicillin Trihydrate ANDA #062883	Ampicillin/Ampicillin Trihydrate	Capsule; Oral	SUPPL-15	Strides Pharma	Labeling	Approved
Ampicillin Trihydrate ANDA #062982	Ampicillin/Ampicillin Trihydrate	For Suspension; Oral	SUPPL-16	Dava Pharms Inc	Labeling	Approved
Ampicillin Trihydrate ANDA #064082	Ampicillin/Ampicillin Trihydrate	Capsule; Oral	SUPPL-22	Sandoz	Labeling	Approved
Ampicillin Trihydrate ANDA #216554	Ampicillin/Ampicillin Trihydrate	Capsule; Oral	SUPPL-1	Aurobindo Pharma	Labeling	Approved
Augmentin '125' NDA #050575	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-51	Us Antibiotics	Labeling	Approved
Augmentin '125' NDA #050597	Amoxicillin; Clavulanate Potassium	Tablet, Chewable; Oral	SUPPL-52	Us Antibiotics	Labeling	Approved
Augmentin '200' NDA #050725	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-36	Us Antibiotics	Labeling	Approved
Augmentin '200' NDA #050726	Amoxicillin; Clavulanate Potassium	Tablet, Chewable; Oral	SUPPL-27	Us Antibiotics	Labeling	Approved
Augmentin '250' NDA #050564	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-60	Us Antibiotics	Labeling	Approved
Augmentin '250' NDA #050575	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-51	Us Antibiotics	Labeling	Approved
Augmentin '250' NDA #050597	Amoxicillin; Clavulanate Potassium	Tablet, Chewable; Oral	SUPPL-52	Us Antibiotics	Labeling	Approved
Augmentin '400' NDA #050725	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-36	Us Antibiotics	Labeling	Approved
Augmentin '400' NDA #050726	Amoxicillin; Clavulanate Potassium	Tablet, Chewable; Oral	SUPPL-27	Us Antibiotics	Labeling	Approved
Augmentin '500' NDA #050564	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-60	Us Antibiotics	Labeling	Approved
Augmentin '875' NDA #050720	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-37	Us Antibiotics	Labeling	Approved
Augmentin Es-600 NDA #050755	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-29	Us Antibiotics	Labeling	Approved
Augmentin Xr NDA #050785	Amoxicillin; Clavulanate Potassium	Tablet, Extended Release; Oral	SUPPL-18	Us Antibiotics	Labeling	Approved
Dexmedetomidine Hydrochloride ANDA #203972	Dexmedetomidine Hydrochloride	Injectable; Injection	SUPPL-14	Par Sterile Products	Labeling	Approved
Dexmedetomidine Hydrochloride ANDA #203972	Dexmedetomidine Hydrochloride	Injectable; Injection	SUPPL-15	Par Sterile Products	Labeling	Approved
Dexmedetomidine Hydrochloride ANDA #208266	Dexmedetomidine Hydrochloride	Injectable; Injection	SUPPL-9	Par Sterile Products	Labeling	Approved
Etodolac ANDA #204729	Etodolac	Tablet; Oral	ORIG-1	Ipca Labs Ltd		Approved
Lansoprazole, Amoxicillin and Clarithromycin (Copackaged) ANDA #200218	Amoxicillin; Clarithromycin; Lansoprazole	Capsule, Tablet, Capsule, Delayed Rel Pellets; Oral	SUPPL-12	Ani Pharms	Labeling	Approved
Larotid ANDA #062226	Amoxicillin	For Suspension; Oral	SUPPL-40	Us Antibiotics	Labeling	Approved
Memantine;Donepezil Hydrochlorides ANDA #216901	Memantine;Donepezil Hydrochlorides	Capsule, Extended Release; Oral	ORIG-1	Xiamen Lp Pharm Co		Tentative Approval
Moxatag NDA #050813	Amoxicillin	Tablet, Extended Release; Oral	SUPPL-10	Pragma	Labeling	Approved
Mycophenolate Mofetil ANDA #212634	Mycophenolate Mofetil	For Suspension; Oral	SUPPL-1	Strides Pharma	Labeling	Approved
Mycophenolate Mofetil ANDA #212634	Mycophenolate Mofetil	For Suspension; Oral	SUPPL-1	Strides Pharma	Labeling	Approved
Myhibbin NDA #216482	Mycophenolate Mofetil	Suspension; Oral	ORIG-1	Azurity Pharmaceuticals Inc	Type 5 - New Formulation or New Manufacturer	Approved
Omeprazole and Clarithromycin and Amoxicillin NDA #050824	Amoxicillin; Clarithromycin; Omeprazole	Capsule, Tablet, Capsule, Delayed Release; Oral	SUPPL-13	Cumberland	Labeling	Approved
Oseltamivir Phosphate ANDA #218565	Oseltamivir Phosphate	Capsule; Oral	ORIG-1	Laurus		Approved
Oxymorphone Hydrochloride ANDA #204459	Oxymorphone Hydrochloride	Tablet; Oral	SUPPL-7	Aurolife Pharma Llc	Labeling	Approved
Oxymorphone Hydrochloride ANDA #204459	Oxymorphone Hydrochloride	Tablet; Oral	SUPPL-8	Aurolife Pharma Llc	Labeling	Approved
Oxymorphone Hydrochloride ANDA #204459	Oxymorphone Hydrochloride	Tablet; Oral	SUPPL-9	Aurolife Pharma Llc	Labeling	Approved
Oxymorphone Hydrochloride ANDA #204459	Oxymorphone Hydrochloride	Tablet; Oral	SUPPL-10	Aurolife Pharma Llc	Labeling	Approved
Oxymorphone Hydrochloride ANDA #204459	Oxymorphone Hydrochloride	Tablet; Oral	SUPPL-7	Aurolife Pharma Llc	Labeling	Approved
Oxymorphone Hydrochloride ANDA #204459	Oxymorphone Hydrochloride	Tablet; Oral	SUPPL-8	Aurolife Pharma Llc	Labeling	Approved
Oxymorphone Hydrochloride ANDA #204459	Oxymorphone Hydrochloride	Tablet; Oral	SUPPL-9	Aurolife Pharma Llc	Labeling	Approved
Oxymorphone Hydrochloride ANDA #204459	Oxymorphone Hydrochloride	Tablet; Oral	SUPPL-10	Aurolife Pharma Llc	Labeling	Approved
Piperacillin ANDA #065114	Piperacillin Sodium	Injectable; Injection	SUPPL-18	Istituto Bio Ita Spa	Labeling	Approved
Piperacillin ANDA #065157	Piperacillin Sodium	Injectable; Injection	SUPPL-15	Istituto Bio Ita Spa	Labeling	Approved
Piperacillin and Tazobactam ANDA #065362	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-44	Sandoz	Labeling	Approved
Piperacillin and Tazobactam ANDA #065363	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-47	Sandoz	Labeling	Approved
Piperacillin and Tazobactam ANDA #065458	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-16	Steriscience	Labeling	Approved
Piperacillin and Tazobactam ANDA #065498	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-26	Eugia Pharma Speclts	Labeling	Approved
Piperacillin and Tazobactam ANDA #065523	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-30	Istituto Bio Ita Spa	Labeling	Approved
Piperacillin and Tazobactam ANDA #090498	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-24	Istituto Bio Ita Spa	Labeling	Approved
Piperacillin and Tazobactam ANDA #203557	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-35	Sandoz	Labeling	Approved
Piperacillin and Tazobactam ANDA #203719	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-12	Fresenius Kabi	Labeling	Approved
Piperacillin and Tazobactam ANDA #203720	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-11	Fresenius Kabi	Labeling	Approved
Piperacillin and Tazobactam ANDA #204959	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-13	Shandong	Labeling	Approved
Piperacillin and Tazobactam ANDA #206996	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-9	Wockhardt Bio Ag	Labeling	Approved
Piperacillin and Tazobactam ANDA #207146	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-9	Wockhardt Bio Ag	Labeling	Approved
Piperacillin and Tazobactam ANDA #207847	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-15	Provepharm Sas	Labeling	Approved
Piperacillin and Tazobactam ANDA #207848	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-15	Provepharm Sas	Labeling	Approved
Piperacillin and Tazobactam ANDA #208674	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-5	Sagent Pharms Inc	Labeling	Approved
Piperacillin and Tazobactam ANDA #208675	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-5	Sagent Pharms Inc	Labeling	Approved
Piperacillin and Tazobactam ANDA #217243	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-4	Shandong	Labeling	Approved
Piperacillin and Tazobactam ANDA #217409	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-1	Eugia Pharma	Labeling	Approved
Piperacillin and Tazobactam ANDA #217409	Piperacillin,Tazobactam	Injection; Powder,For Solution	SUPPL-1	Eugia Pharma	Labeling	Approved
Probampacin ANDA #061741	Ampicillin/Ampicillin Trihydrate; Probenecid	For Suspension; Oral	SUPPL-1	Cosette	Labeling	Approved
Sugammadex ANDA #214230	Sugammadex	Injectable; Injection	ORIG-1	Mankind Pharma		Tentative Approval
Talicia NDA #213004	Amoxicillin; Omeprazole Magnesium; Rifabutin	Capsule, Delayed Release; Oral	SUPPL-14	Redhill	Labeling	Approved
Unasyn NDA #050608	Ampicillin Sodium; Sulbactam Sodium	Injectable; Injection	SUPPL-53	Pfizer	Labeling	Approved
Voquezna Dual Pak NDA #215153	Amoxicillin; Vonoprazan Fumarate	Capsule, Tablet; Oral	SUPPL-7	Phathom	Labeling	Approved
Voquezna Triple Pak NDA #215152	Amoxicillin; Clarithromycin; Vonoprazan Fumarate	Capsule, Tablet, Tablet; Oral	SUPPL-7	Phathom	Labeling	Approved
Zosyn NDA #050684	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-104	Wyeth Pharms	Labeling	Approved
Zosyn In Plastic Container NDA #050750	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-51	Baxter Hlthcare Corp	Labeling	Approved

April 30, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Abrilada BLA #761118	Adalimumab-Afzb	Injectable; Injection	SUPPL-12	Pfizer Inc	Labeling	Approved
Abrilada BLA #761118	Adalimumab-Afzb	Injectable; Injection	SUPPL-12	Pfizer Inc	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #090227	Amoxicillin; Clavulanate Potassium	Tablet, Extended Release; Oral	SUPPL-18	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #090227	Amoxicillin; Clavulanate Potassium	Tablet, Extended Release; Oral	SUPPL-18	Sandoz	Labeling	Approved
Aranesp BLA #103951	Darbepoetin Alfa	Vial; Intravenous	SUPPL-5383	Amgen	Labeling	Approved
Aranesp BLA #103951	Darbepoetin Alfa	Vial; Intravenous	SUPPL-5383	Amgen	Labeling	Approved
Aranesp BLA #103951	Darbepoetin Alfa	Vial; Subcutaneous	SUPPL-5383	Amgen	Labeling	Approved
Aranesp BLA #103951	Darbepoetin Alfa	Vial; Subcutaneous	SUPPL-5383	Amgen	Labeling	Approved
Bromfenac Sodium ANDA #210962	Bromfenac Sodium	Unknown	ORIG-1	Amneal Pharms Co		Tentative Approval
Camzyos NDA #214998	Mavacamten	Capsule; Oral	SUPPL-9	Bristol	Labeling	Approved
Cupric Chloride ANDA #216113	Cupric Chloride	Injectable; Injection	ORIG-1	Somerset		Approved
Cupric Chloride ANDA #217626	Cupric Chloride	Injectable; Injection	ORIG-1	Stira		Approved
Cyltezo BLA #761058	Adalimumab-Adbm	Injectable; Injection	SUPPL-26	Boehringer Ingelheim	Efficacy	Approved
Dimethyl Fumarate ANDA #210531	Dimethyl Fumarate	Capsule, Delayed Release; Oral	SUPPL-3	Mylan	Labeling	Approved
Dimethyl Fumarate ANDA #210531	Dimethyl Fumarate	Capsule, Delayed Release; Oral	SUPPL-6	Mylan	Labeling	Approved
Dimethyl Fumarate ANDA #210531	Dimethyl Fumarate	Capsule, Delayed Release; Oral	SUPPL-10	Mylan	Labeling	Approved
Dimethyl Fumarate ANDA #210531	Dimethyl Fumarate	Capsule, Delayed Release; Oral	SUPPL-12	Mylan	Labeling	Approved
Dimethyl Fumarate ANDA #210531	Dimethyl Fumarate	Capsule, Delayed Release; Oral	SUPPL-3	Mylan	Labeling	Approved
Dimethyl Fumarate ANDA #210531	Dimethyl Fumarate	Capsule, Delayed Release; Oral	SUPPL-6	Mylan	Labeling	Approved
Dimethyl Fumarate ANDA #210531	Dimethyl Fumarate	Capsule, Delayed Release; Oral	SUPPL-10	Mylan	Labeling	Approved
Dimethyl Fumarate ANDA #210531	Dimethyl Fumarate	Capsule, Delayed Release; Oral	SUPPL-12	Mylan	Labeling	Approved
Dimethyl Fumarate ANDA #210531	Dimethyl Fumarate	Capsule, Delayed Release; Oral	SUPPL-13	Mylan	Labeling	Approved
Dofetilide ANDA #212750	Dofetilide	Capsule; Oral	SUPPL-2	Granules	Labeling	Approved
Dofetilide ANDA #212750	Dofetilide	Capsule; Oral	SUPPL-2	Granules	Labeling	Approved
Dofetilide ANDA #212750	Dofetilide	Capsule; Oral	SUPPL-2	Granules	Labeling	Approved
Epogen/Procrit BLA #103234	Epoetin Alfa	Vial; Multidose	SUPPL-5378	Amgen	Labeling	Approved
Epogen/Procrit BLA #103234	Epoetin Alfa	Vial; Multidose	SUPPL-5378	Amgen	Labeling	Approved
Epogen/Procrit BLA #103234	Epoetin Alfa	Vial; Single-Use	SUPPL-5378	Amgen	Labeling	Approved
Epogen/Procrit BLA #103234	Epoetin Alfa	Vial; Single-Use	SUPPL-5378	Amgen	Labeling	Approved
Esomeprazole Magnesium ANDA #207198	Esomeprazole Magnesium	Capsule, Delayed Release; Oral	ORIG-1	Dr Reddys		Approved
Everolimus ANDA #206133	Everolimus	Tablet; Oral	SUPPL-6	Hikma	Labeling	Approved
Ezetimibe ANDA #207311	Ezetimibe	Tablet; Oral	SUPPL-12	Ohm Labs Inc	Labeling	Approved
Hydrochlorothiazide ANDA #202556	Hydrochlorothiazide	Tablet; Oral	SUPPL-8	Accord Hlthcare	Labeling	Approved
Hydrochlorothiazide ANDA #203561	Hydrochlorothiazide	Capsule; Oral	SUPPL-3	Sciegen Pharms Inc	Labeling	Approved
Hydrochlorothiazide ANDA #203561	Hydrochlorothiazide	Capsule; Oral	SUPPL-5	Sciegen Pharms Inc	Labeling	Approved
Hydrocortisone Butyrate ANDA #209556	Hydrocortisone Butyrate	Lotion; Topical	SUPPL-4	The J Molner	Labeling	Approved
Hydrocortisone Butyrate ANDA #209556	Hydrocortisone Butyrate	Lotion; Topical	SUPPL-4	The J Molner	Labeling	Approved
Ingrezza Sprinkle NDA #218390	Valbenazine	Capsule; Oral	ORIG-1	Neurocrine		Approved
Linezolid ANDA #204536	Linezolid	Tablet; Oral	SUPPL-7	Amneal Pharms	Labeling	Approved
Linezolid ANDA #204536	Linezolid	Tablet; Oral	SUPPL-8	Amneal Pharms	Labeling	Approved
Linezolid ANDA #204536	Linezolid	Tablet; Oral	SUPPL-9	Amneal Pharms	Labeling	Approved
Losartan Potassium and Hydrochlorothiazide ANDA #201845	Hydrochlorothiazide; Losartan Potassium	Tablet; Oral	SUPPL-20	Jubilant Cadista	Labeling	Approved
Losartan Potassium and Hydrochlorothiazide ANDA #201845	Hydrochlorothiazide; Losartan Potassium	Tablet; Oral	SUPPL-20	Jubilant Cadista	Labeling	Approved
Meperidine Hydrochloride ANDA #040186	Meperidine Hydrochloride	Tablet; Oral	SUPPL-13	Watson Labs	Labeling	Approved
Meperidine Hydrochloride ANDA #040186	Meperidine Hydrochloride	Tablet; Oral	SUPPL-13	Watson Labs	Labeling	Approved
Meperidine Hydrochloride ANDA #080448	Meperidine Hydrochloride	Tablet; Oral	SUPPL-23	Sun Pharm Industries	Labeling	Approved
Meperidine Hydrochloride ANDA #080448	Meperidine Hydrochloride	Tablet; Oral	SUPPL-23	Sun Pharm Industries	Labeling	Approved
Mircera BLA #125164	Methoxy Polyethylene Glycol-Epoetin Beta	Solution; Injection	SUPPL-89	Hoffman-La Roche	Efficacy	Approved
Myfembree NDA #214846	Estradiol; Norethindrone Acetate; Relugolix	Tablet; Oral	SUPPL-7	Myovant Sciences	Efficacy	Approved
Nicorette NDA #022360	Nicotine Polacrilex	Troche/Lozenge; Oral	SUPPL-17	Haleon Us Holdings	Labeling	Approved
Nicotine Polacrilex ANDA #076778	Nicotine Polacrilex	Gum, Chewing; Buccal	SUPPL-19	L Perrigo Co	Labeling	Approved
Nicotine Polacrilex ANDA #076778	Nicotine Polacrilex	Gum, Chewing; Buccal	SUPPL-19	L Perrigo Co	Labeling	Approved
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate ANDA #202742	Ethinyl Estradiol; Norethindrone Acetate	Tablet; Oral	SUPPL-10	Mylan Labs Ltd	Labeling	Approved
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate ANDA #202742	Ethinyl Estradiol; Norethindrone Acetate	Tablet; Oral	SUPPL-12	Mylan Labs Ltd	Labeling	Approved
Pitavastatin Calcium ANDA #205977	Pitavastatin Calcium	Tablet; Oral	ORIG-1	Hetero Labs Ltd V		Approved
Sevelamer Carbonate ANDA #207179	Sevelamer Carbonate	Tablet; Oral	SUPPL-11	Aurobindo Pharma	Labeling	Approved
Sotalol Hydrochloride ANDA #077616	Sotalol Hydrochloride	Tablet; Oral	SUPPL-8	Aurobindo Pharma Usa	Labeling	Approved
Sotalol Hydrochloride ANDA #077616	Sotalol Hydrochloride	Tablet; Oral	SUPPL-5	Aurobindo Pharma Usa	Labeling	Approved
Sotalol Hydrochloride ANDA #077616	Sotalol Hydrochloride	Tablet; Oral	SUPPL-8	Aurobindo Pharma Usa	Labeling	Approved
Ursodiol ANDA #075517	Ursodiol	Capsule; Oral	SUPPL-18	Epic Pharma	Labeling	Approved
Valsartan and Hydrochlorothiazide ANDA #201662	Hydrochlorothiazide; Valsartan	Tablet; Oral	SUPPL-26	Alembic	Labeling	Approved
Valsartan and Hydrochlorothiazide ANDA #201662	Hydrochlorothiazide; Valsartan	Tablet; Oral	SUPPL-26	Alembic	Labeling	Approved
Valsartan and Hydrochlorothiazide ANDA #203000	Hydrochlorothiazide; Valsartan	Tablet; Oral	SUPPL-1	Zydus Lifesciences	Labeling	Approved
Valsartan and Hydrochlorothiazide ANDA #203000	Hydrochlorothiazide; Valsartan	Tablet; Oral	SUPPL-2	Zydus Lifesciences	Labeling	Approved
Valsartan and Hydrochlorothiazide ANDA #203000	Hydrochlorothiazide; Valsartan	Tablet; Oral	SUPPL-1	Zydus Lifesciences	Labeling	Approved
Valsartan and Hydrochlorothiazide ANDA #203000	Hydrochlorothiazide; Valsartan	Tablet; Oral	SUPPL-2	Zydus Lifesciences	Labeling	Approved
Vasopressin NDA #217766	Vasopressin	Injectable; Injection	ORIG-1	Long Grove Pharms	Type 3 - New Dosage Form	Tentative Approval

April 29, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Amoxicillin and Clavulanate Potassium ANDA #065063	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-48	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065064	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-47	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065065	Amoxicillin; Clavulanate Potassium	Tablet, Chewable; Oral	SUPPL-34	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065066	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-45	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065189	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-28	Sandoz	Labeling	Approved
Atropine Sulfate ANDA #217791	Atropine Sulfate	Solution/Drops; Ophthalmic	ORIG-1	Somerset		Approved
Besremi BLA #761166	Ropeginterferon Alfa-2b-Njft	Injectable; Subcutaneous	SUPPL-7	Pharmaessentia Corp	Labeling	Approved
Colchicine ANDA #210757	Colchicine	Capsule; Oral	ORIG-1	Granules		Approved
Colchicine ANDA #215463	Colchicine	Capsule; Oral	ORIG-1	Aurobindo Pharma Ltd		Approved
Colchicine ANDA #217620	Colchicine	Capsule; Oral	ORIG-1	Annora Pharma		Approved
Ezetimibe ANDA #211159	Ezetimibe	Tablet; Oral	ORIG-1	Macleods Pharms Ltd		Approved
Givlaari NDA #212194	Givosiran Sodium	Solution; Subcutaneous	SUPPL-7	Alnylam Pharms Inc	Labeling	Approved
Lanoxin NDA #020405	Digoxin	Tablet; Oral	SUPPL-17	Concordia	Labeling	Approved
Lidocaine Hydrochloride ANDA #218411	Lidocaine Hydrochloride	Solution; Topical	ORIG-1	The J Molner		Approved
Lupkynis NDA #213716	Voclosporin	Capsule; Oral	SUPPL-4	Aurinia	Efficacy	Approved
Lupkynis NDA #213716	Voclosporin	Capsule; Oral	SUPPL-4	Aurinia	Efficacy	Approved
Lupkynis NDA #213716	Voclosporin	Capsule; Oral	SUPPL-4	Aurinia	Efficacy	Approved
Midostaurin ANDA #216076	Midostaurin	Capsule; Oral	ORIG-1	Teva Pharms		Approved
Omvoh BLA #761279	Mirikizumab-Mrkz	Injectable; Subcutaneous	SUPPL-1	Eli Lilly and Co	Labeling	Approved
Omvoh BLA #761279	Mirikizumab-Mrkz	Injectable; Subcutaneous	SUPPL-1	Eli Lilly and Co	Labeling	Approved
Omvoh BLA #761279	Mirikizumab-Mrkz	Injectable; Subcutaneous	SUPPL-1	Eli Lilly and Co	Labeling	Approved
Omvoh BLA #761279	Mirikizumab-Mrkz	Vial; Single-Use	SUPPL-1	Eli Lilly and Co	Labeling	Approved
Omvoh BLA #761279	Mirikizumab-Mrkz	Vial; Single-Use	SUPPL-1	Eli Lilly and Co	Labeling	Approved
Omvoh BLA #761279	Mirikizumab-Mrkz	Vial; Single-Use	SUPPL-1	Eli Lilly and Co	Labeling	Approved
Tagrisso NDA #208065	Osimertinib Mesylate	Tablet; Oral	SUPPL-31	Astrazeneca	Labeling	Approved
Tivdak BLA #761208	Tisotumab Vedotin-Tftv	Injectable; Injection	SUPPL-7	Seagen	Efficacy	Approved
Tretinoin ANDA #217804	Tretinoin	Cream; Topical	ORIG-1	Alembic		Approved
Truvada NDA #021752	Emtricitabine; Tenofovir Disoproxil Fumarate	Tablet; Oral	SUPPL-64	Gilead	Labeling	Approved
Truvada NDA #021752	Emtricitabine; Tenofovir Disoproxil Fumarate	Tablet; Oral	SUPPL-64	Gilead	Labeling	Approved

April 26, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Acetaminophen and Ibuprofen ANDA #218311	Acetaminophen; Ibuprofen	Tablet; Oral	ORIG-1	Glenmark Pharms Ltd		Approved
Amoxicillin and Clavulanate Potassium ANDA #065162	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-36	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065162	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-29	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065162	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-32	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065162	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-36	Teva	Labeling	Approved
Clindamycin Phosphate ANDA #064050	Clindamycin Phosphate	Solution; Topical	SUPPL-24	Padagis Us	Manufacturing (CMC)	Approved
Clindamycin Phosphate ANDA #064050	Clindamycin Phosphate	Solution; Topical	SUPPL-24	Padagis Us	Manufacturing (CMC)	Approved
Libervant NDA #218623	Diazepam	Film; Buccal	ORIG-1	Aquestive Therapeutics Inc	Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval	Approved
Rinvoq NDA #211675	Upadacitinib	Tablet, Extended Release; Oral	SUPPL-21	Abbvie	Efficacy	Approved
Rinvoq NDA #211675	Upadacitinib	Tablet, Extended Release; Oral	SUPPL-22	Abbvie	Efficacy	Approved
Rinvoq NDA #218347	Upadacitinib	Tablet, Extended Release; Oral	ORIG-1	Abbvie Inc	Type 3 - New Dosage Form	Approved
Rinvoq Lq NDA #218347	Upadacitinib	Solution; Oral	ORIG-1	Abbvie Inc	Type 3 - New Dosage Form	Approved
Xolremdi NDA #218709	Mavorixafor	Capsule; Oral	ORIG-1	X4 Pharmaceuticals Inc	Type 1 - New Molecular Entity	Approved
Zilbrysq NDA #216834	Zilucoplan Sodium	Solution; Subcutaneous	SUPPL-1	Ucb Inc	Labeling	Approved

April 25, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Amoxicillin ANDA #062881	Amoxicillin	Capsule; Oral	SUPPL-26	Strides Pharma	Labeling	Approved
Amoxicillin ANDA #062881	Amoxicillin	Capsule; Oral	SUPPL-27	Strides Pharma	Labeling	Approved
Amoxicillin ANDA #062881	Amoxicillin	Capsule; Oral	SUPPL-28	Strides Pharma	Labeling	Approved
Amoxicillin ANDA #062884	Amoxicillin	Capsule; Oral	SUPPL-24	Strides Pharma	Labeling	Approved
Amoxicillin ANDA #062884	Amoxicillin	Capsule; Oral	SUPPL-23	Strides Pharma	Labeling	Approved
Amoxicillin ANDA #062884	Amoxicillin	Capsule; Oral	SUPPL-24	Strides Pharma	Labeling	Approved
Amoxicillin ANDA #062884	Amoxicillin	Capsule; Oral	SUPPL-25	Strides Pharma	Labeling	Approved
Amoxicillin ANDA #064076	Amoxicillin	Capsule; Oral	SUPPL-37	Sandoz	Labeling	Approved
Amoxicillin ANDA #064139	Amoxicillin	Tablet, Chewable; Oral	SUPPL-13	Chartwell Rx	Labeling	Approved
Amoxicillin ANDA #064139	Amoxicillin	Tablet, Chewable; Oral	SUPPL-14	Chartwell Rx	Labeling	Approved
Amoxicillin ANDA #064139	Amoxicillin	Tablet, Chewable; Oral	SUPPL-15	Chartwell Rx	Labeling	Approved
Amoxicillin ANDA #065228	Amoxicillin	Tablet; Oral	SUPPL-17	Sandoz	Labeling	Approved
Amoxicillin ANDA #065228	Amoxicillin	Tablet; Oral	SUPPL-17	Sandoz	Labeling	Approved
Amoxicillin ANDA #065228	Amoxicillin	Tablet; Oral	SUPPL-19	Sandoz	Labeling	Approved
Amoxicillin ANDA #065255	Amoxicillin	Tablet; Oral	SUPPL-25	Hikma	Labeling	Approved
Amoxicillin ANDA #065325	Amoxicillin	For Suspension; Oral	SUPPL-32	Hikma	Labeling	Approved
Amoxicillin ANDA #065344	Amoxicillin	Tablet; Oral	SUPPL-5	Chartwell Rx	Labeling	Approved
Amoxicillin ANDA #065344	Amoxicillin	Tablet; Oral	SUPPL-6	Chartwell Rx	Labeling	Approved
Amoxicillin ANDA #065344	Amoxicillin	Tablet; Oral	SUPPL-7	Chartwell Rx	Labeling	Approved
Amoxicillin ANDA #065378	Amoxicillin	For Suspension; Oral	SUPPL-18	Sandoz	Labeling	Approved
Amoxicillin ANDA #065387	Amoxicillin	For Suspension; Oral	SUPPL-18	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #201090	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-11	Aurobindo Pharma Ltd	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #201090	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-5	Aurobindo Pharma Ltd	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #201090	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-11	Aurobindo Pharma Ltd	Labeling	Approved
Amrix NDA #021777	Cyclobenzaprine Hydrochloride	Capsule, Extended Release; Oral	SUPPL-19	Teva Pharms Intl	Labeling	Approved
Brinzolamide ANDA #204884	Brinzolamide	Suspension/Drops; Ophthalmic	SUPPL-7	Bausch and Lomb	Labeling	Approved
Cetrorelix Acetate ANDA #218150	Cetrorelix Acetate	Powder; Subcutaneous	ORIG-1	Gland		Approved
Deflazacort ANDA #217813	Deflazacort	Suspension; Oral	ORIG-1	Tris Pharma Inc		Approved
Diazepam ANDA #218450	Diazepam	Injectable; Injection	ORIG-1	Alembic		Approved
Digoxin NDA #021648	Digoxin	Elixir; Oral	SUPPL-15	Hikma	Labeling	Approved
Digoxin NDA #021648	Digoxin	Elixir; Oral	SUPPL-15	Hikma	Labeling	Approved
Eslicarbazepine Acetate ANDA #211247	Eslicarbazepine Acetate	Unknown	ORIG-1	Sph Shanghai Zhongxi Pharma Co Ltd		Tentative Approval
Galzin NDA #020458	Zinc Acetate	Capsule; Oral	SUPPL-9	Teva	Labeling	Approved
Hercessi BLA #761346	Trastuzumab-Strf	Injectable; Injection	ORIG-1	Accord Biopharma Inc.		Approved
Otezla NDA #205437	Apremilast	Tablet; Oral	SUPPL-13	Amgen Inc	Efficacy	Approved
Safinamide Mesylate ANDA #215739	Safinamide Mesylate	Tablet; Oral	ORIG-1	Prinston Inc		Approved
Sevelamer Carbonate ANDA #207291	Sevelamer Carbonate	For Suspension; Oral	ORIG-1	Macleods Pharms Ltd		Approved
Trandate NDA #018716	Labetalol Hydrochloride	Tablet; Oral	SUPPL-36	Alvogen	Labeling	Approved
Tretinoin ANDA #218561	Tretinoin	Cream; Topical	ORIG-1	Zydus Lifesciences		Approved
Viorele ANDA #091346	Desogestrel; Ethinyl Estradiol	Tablet; Oral-28	SUPPL-16	Glenmark Pharms Ltd	Manufacturing (CMC)	Approved
Zinc Chloride In Plastic Container NDA #018959	Zinc Chloride	Injectable; Injection	SUPPL-32	Hospira	Labeling	Approved

May 2, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Esmolol Hydrochloride Double Strength In Plastic Container NDA #205703	Esmolol Hydrochloride	Solution; Intravenous	SUPPL-3	Hq Spclt Pharma	Labeling	Approved
Esmolol Hydrochloride In Plastic Container NDA #205703	Esmolol Hydrochloride	Solution; Intravenous	SUPPL-3	Hq Spclt Pharma	Labeling	Approved

May 1, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Amoxicillin ANDA #061926	Amoxicillin	Capsule; Oral	SUPPL-136	Teva	Labeling	Approved
Amoxicillin ANDA #061931	Amoxicillin	For Suspension; Oral	SUPPL-60	Teva	Labeling	Approved
Amoxicillin ANDA #062058	Amoxicillin	Capsule; Oral	SUPPL-15	Chartwell	Labeling	Approved
Amoxicillin ANDA #062059	Amoxicillin	For Suspension; Oral	SUPPL-6	Chartwell Rx	Labeling	Approved
Amoxicillin ANDA #062881	Amoxicillin	Capsule; Oral	SUPPL-29	Strides Pharma	Labeling	Approved
Amoxicillin ANDA #062884	Amoxicillin	Capsule; Oral	SUPPL-26	Strides Pharma	Labeling	Approved
Amoxicillin ANDA #062927	Amoxicillin	For Suspension; Oral	SUPPL-29	Dava Pharms Inc	Labeling	Approved
Amoxicillin ANDA #064013	Amoxicillin	Tablet, Chewable; Oral	SUPPL-64	Teva	Labeling	Approved
Amoxicillin ANDA #064076	Amoxicillin	Capsule; Oral	SUPPL-38	Sandoz	Labeling	Approved
Amoxicillin ANDA #064139	Amoxicillin	Tablet, Chewable; Oral	SUPPL-16	Chartwell Rx	Labeling	Approved
Amoxicillin ANDA #065056	Amoxicillin	Tablet; Oral	SUPPL-26	Teva	Labeling	Approved
Amoxicillin ANDA #065119	Amoxicillin	For Suspension; Oral	SUPPL-33	Teva	Labeling	Approved
Amoxicillin ANDA #065228	Amoxicillin	Tablet; Oral	SUPPL-20	Sandoz	Labeling	Approved
Amoxicillin ANDA #065255	Amoxicillin	Tablet; Oral	SUPPL-28	Hikma	Labeling	Approved
Amoxicillin ANDA #065256	Amoxicillin	Tablet; Oral	SUPPL-25	Aurobindo	Labeling	Approved
Amoxicillin ANDA #065271	Amoxicillin	Capsule; Oral	SUPPL-25	Aurobindo	Labeling	Approved
Amoxicillin ANDA #065291	Amoxicillin	Capsule; Oral	SUPPL-33	Hikma Pharms	Labeling	Approved
Amoxicillin ANDA #065322	Amoxicillin	For Suspension; Oral	SUPPL-39	Hikma	Labeling	Approved
Amoxicillin ANDA #065325	Amoxicillin	For Suspension; Oral	SUPPL-35	Hikma	Labeling	Approved
Amoxicillin ANDA #065334	Amoxicillin	For Suspension; Oral	SUPPL-25	Aurobindo	Labeling	Approved
Amoxicillin ANDA #065344	Amoxicillin	Tablet; Oral	SUPPL-8	Chartwell Rx	Labeling	Approved
Amoxicillin ANDA #065378	Amoxicillin	For Suspension; Oral	SUPPL-19	Sandoz	Labeling	Approved
Amoxicillin ANDA #065387	Amoxicillin	For Suspension; Oral	SUPPL-19	Sandoz	Labeling	Approved
Amoxicillin ANDA #204030	Amoxicillin	For Suspension; Oral	SUPPL-13	Aurobindo Pharma Ltd	Labeling	Approved
Amoxicillin ANDA #207471	Amoxicillin	Capsule; Oral	SUPPL-2	Micro Labs	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065063	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-51	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065064	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-50	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065065	Amoxicillin; Clavulanate Potassium	Tablet, Chewable; Oral	SUPPL-35	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065066	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-50	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065089	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-30	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065093	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-33	Sandoz Inc	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065096	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-39	Teva Pharms Usa	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065096	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-39	Teva Pharms Usa	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065098	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-25	Sandoz Inc	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065101	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-38	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065117	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-34	Sandoz Inc	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065162	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-40	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065162	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-40	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065189	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-30	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065191	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-35	Hikma Pharms	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065205	Amoxicillin; Clavulanate Potassium	Tablet, Chewable; Oral	SUPPL-30	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065317	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-4	Apotex Inc	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065317	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-4	Apotex Inc	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065333	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-4	Apotex Inc	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065333	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-4	Apotex Inc	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065373	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-27	Hikma Pharms	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065373	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-23	Hikma Pharms	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065373	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-27	Hikma Pharms	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065373	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-30	Hikma Pharms	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #090227	Amoxicillin; Clavulanate Potassium	Tablet, Extended Release; Oral	SUPPL-19	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #201090	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-14	Aurobindo Pharma Ltd	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #201091	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-13	Aurobindo Pharma Ltd	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #204755	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-12	Micro Labs Ltd India	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #205187	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-4	Micro Labs Ltd India	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #205707	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-12	Micro Labs Ltd India	Labeling	Approved
Amoxicillin Pediatric ANDA #061931	Amoxicillin	For Suspension; Oral	SUPPL-60	Teva	Labeling	Approved
Amoxil NDA #050542	Amoxicillin	Tablet, Chewable; Oral	SUPPL-32	Us Antibiotics	Labeling	Approved
Amoxil NDA #050754	Amoxicillin	Tablet; Oral	SUPPL-22	Us Antibiotics	Labeling	Approved
Amoxil NDA #050760	Amoxicillin	For Suspension; Oral	SUPPL-23	Us Antibiotics	Labeling	Approved
Amoxil NDA #050761	Amoxicillin	Tablet, Chewable; Oral	SUPPL-19	Us Antibiotics	Labeling	Approved
Amoxil ANDA #062216	Amoxicillin	Capsule; Oral	SUPPL-44	Us Antibiotics	Labeling	Approved
Amoxil ANDA #062216	Amoxicillin	Capsule; Oral	SUPPL-44	Us Antibiotics	Labeling	Approved
Amoxil ANDA #062226	Amoxicillin	For Suspension; Oral	SUPPL-40	Us Antibiotics	Labeling	Approved
Ampicillin Sodium ANDA #061395	Ampicillin Sodium	Injectable; Injection	SUPPL-52	Sandoz	Labeling	Approved
Ampicillin Sodium ANDA #062692	Ampicillin Sodium	Injectable; Injection	SUPPL-2	Hikma	Labeling	Approved
Ampicillin Sodium ANDA #062719	Ampicillin Sodium	Injectable; Injection	SUPPL-16	Istituto Bio Ita Spa	Labeling	Approved
Ampicillin Sodium ANDA #062738	Ampicillin Sodium	Powder; Intravenous	SUPPL-33	Sandoz	Labeling	Approved
Ampicillin Sodium ANDA #062772	Ampicillin Sodium	Injectable; Injection	SUPPL-17	Hq Speclt Pharma	Labeling	Approved
Ampicillin Sodium ANDA #062797	Ampicillin Sodium	Injectable; Injection	SUPPL-13	Istituto Bio Ita Spa	Labeling	Approved
Ampicillin Sodium ANDA #063142	Ampicillin Sodium	Injectable; Injection	SUPPL-18	Hq Speclt Pharma	Labeling	Approved
Ampicillin Sodium ANDA #065493	Ampicillin Sodium	Injectable; Injection	SUPPL-11	Eugia Pharma Speclts	Labeling	Approved
Ampicillin Sodium ANDA #065499	Ampicillin Sodium	Injectable; Injection	SUPPL-13	Eugia Pharma Speclts	Labeling	Approved
Ampicillin Sodium ANDA #090354	Ampicillin Sodium	Injectable; Injection	SUPPL-7	Antibiotice	Labeling	Approved
Ampicillin Sodium ANDA #090581	Ampicillin Sodium	Injectable; Injection	SUPPL-5	Sagent Pharms Inc	Labeling	Approved
Ampicillin Sodium ANDA #090583	Ampicillin Sodium	Injectable; Injection	SUPPL-5	Sagent Pharms Inc	Labeling	Approved
Ampicillin Sodium ANDA #090884	Ampicillin Sodium	Injectable; Injection	SUPPL-3	Acs Dobfar Spa	Labeling	Approved
Ampicillin Sodium ANDA #090889	Ampicillin Sodium	Injectable; Injection	SUPPL-3	Acs Dobfar Spa	Labeling	Approved
Ampicillin Sodium ANDA #201025	Ampicillin Sodium	Injectable; Injection	SUPPL-10	Steriscience	Labeling	Approved
Ampicillin Sodium ANDA #201404	Ampicillin Sodium	Injectable; Injection	SUPPL-8	Istituto Bio Ita Spa	Labeling	Approved
Ampicillin Sodium ANDA #202198	Ampicillin Sodium	Injectable; Injection	SUPPL-7	Steriscience	Labeling	Approved
Ampicillin Trihydrate ANDA #061502	Ampicillin/Ampicillin Trihydrate	Capsule; Oral	SUPPL-140	Chartwell Rx	Labeling	Approved
Ampicillin Trihydrate ANDA #062882	Ampicillin/Ampicillin Trihydrate	Capsule; Oral	SUPPL-17	Strides Pharma	Labeling	Approved
Ampicillin Trihydrate ANDA #062883	Ampicillin/Ampicillin Trihydrate	Capsule; Oral	SUPPL-15	Strides Pharma	Labeling	Approved
Ampicillin Trihydrate ANDA #062982	Ampicillin/Ampicillin Trihydrate	For Suspension; Oral	SUPPL-16	Dava Pharms Inc	Labeling	Approved
Ampicillin Trihydrate ANDA #064082	Ampicillin/Ampicillin Trihydrate	Capsule; Oral	SUPPL-22	Sandoz	Labeling	Approved
Ampicillin Trihydrate ANDA #216554	Ampicillin/Ampicillin Trihydrate	Capsule; Oral	SUPPL-1	Aurobindo Pharma	Labeling	Approved
Augmentin '125' NDA #050575	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-51	Us Antibiotics	Labeling	Approved
Augmentin '125' NDA #050597	Amoxicillin; Clavulanate Potassium	Tablet, Chewable; Oral	SUPPL-52	Us Antibiotics	Labeling	Approved
Augmentin '200' NDA #050725	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-36	Us Antibiotics	Labeling	Approved
Augmentin '200' NDA #050726	Amoxicillin; Clavulanate Potassium	Tablet, Chewable; Oral	SUPPL-27	Us Antibiotics	Labeling	Approved
Augmentin '250' NDA #050564	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-60	Us Antibiotics	Labeling	Approved
Augmentin '250' NDA #050575	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-51	Us Antibiotics	Labeling	Approved
Augmentin '250' NDA #050597	Amoxicillin; Clavulanate Potassium	Tablet, Chewable; Oral	SUPPL-52	Us Antibiotics	Labeling	Approved
Augmentin '400' NDA #050725	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-36	Us Antibiotics	Labeling	Approved
Augmentin '400' NDA #050726	Amoxicillin; Clavulanate Potassium	Tablet, Chewable; Oral	SUPPL-27	Us Antibiotics	Labeling	Approved
Augmentin '500' NDA #050564	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-60	Us Antibiotics	Labeling	Approved
Augmentin '875' NDA #050720	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-37	Us Antibiotics	Labeling	Approved
Augmentin Es-600 NDA #050755	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-29	Us Antibiotics	Labeling	Approved
Augmentin Xr NDA #050785	Amoxicillin; Clavulanate Potassium	Tablet, Extended Release; Oral	SUPPL-18	Us Antibiotics	Labeling	Approved
Dexmedetomidine Hydrochloride ANDA #203972	Dexmedetomidine Hydrochloride	Injectable; Injection	SUPPL-14	Par Sterile Products	Labeling	Approved
Dexmedetomidine Hydrochloride ANDA #203972	Dexmedetomidine Hydrochloride	Injectable; Injection	SUPPL-15	Par Sterile Products	Labeling	Approved
Dexmedetomidine Hydrochloride ANDA #208266	Dexmedetomidine Hydrochloride	Injectable; Injection	SUPPL-9	Par Sterile Products	Labeling	Approved
Etodolac ANDA #204729	Etodolac	Tablet; Oral	ORIG-1	Ipca Labs Ltd		Approved
Lansoprazole, Amoxicillin and Clarithromycin (Copackaged) ANDA #200218	Amoxicillin; Clarithromycin; Lansoprazole	Capsule, Tablet, Capsule, Delayed Rel Pellets; Oral	SUPPL-12	Ani Pharms	Labeling	Approved
Larotid ANDA #062226	Amoxicillin	For Suspension; Oral	SUPPL-40	Us Antibiotics	Labeling	Approved
Memantine;Donepezil Hydrochlorides ANDA #216901	Memantine;Donepezil Hydrochlorides	Capsule, Extended Release; Oral	ORIG-1	Xiamen Lp Pharm Co		Tentative Approval
Moxatag NDA #050813	Amoxicillin	Tablet, Extended Release; Oral	SUPPL-10	Pragma	Labeling	Approved
Mycophenolate Mofetil ANDA #212634	Mycophenolate Mofetil	For Suspension; Oral	SUPPL-1	Strides Pharma	Labeling	Approved
Mycophenolate Mofetil ANDA #212634	Mycophenolate Mofetil	For Suspension; Oral	SUPPL-1	Strides Pharma	Labeling	Approved
Myhibbin NDA #216482	Mycophenolate Mofetil	Suspension; Oral	ORIG-1	Azurity Pharmaceuticals Inc	Type 5 - New Formulation or New Manufacturer	Approved
Omeprazole and Clarithromycin and Amoxicillin NDA #050824	Amoxicillin; Clarithromycin; Omeprazole	Capsule, Tablet, Capsule, Delayed Release; Oral	SUPPL-13	Cumberland	Labeling	Approved
Oseltamivir Phosphate ANDA #218565	Oseltamivir Phosphate	Capsule; Oral	ORIG-1	Laurus		Approved
Oxymorphone Hydrochloride ANDA #204459	Oxymorphone Hydrochloride	Tablet; Oral	SUPPL-7	Aurolife Pharma Llc	Labeling	Approved
Oxymorphone Hydrochloride ANDA #204459	Oxymorphone Hydrochloride	Tablet; Oral	SUPPL-8	Aurolife Pharma Llc	Labeling	Approved
Oxymorphone Hydrochloride ANDA #204459	Oxymorphone Hydrochloride	Tablet; Oral	SUPPL-9	Aurolife Pharma Llc	Labeling	Approved
Oxymorphone Hydrochloride ANDA #204459	Oxymorphone Hydrochloride	Tablet; Oral	SUPPL-10	Aurolife Pharma Llc	Labeling	Approved
Oxymorphone Hydrochloride ANDA #204459	Oxymorphone Hydrochloride	Tablet; Oral	SUPPL-7	Aurolife Pharma Llc	Labeling	Approved
Oxymorphone Hydrochloride ANDA #204459	Oxymorphone Hydrochloride	Tablet; Oral	SUPPL-8	Aurolife Pharma Llc	Labeling	Approved
Oxymorphone Hydrochloride ANDA #204459	Oxymorphone Hydrochloride	Tablet; Oral	SUPPL-9	Aurolife Pharma Llc	Labeling	Approved
Oxymorphone Hydrochloride ANDA #204459	Oxymorphone Hydrochloride	Tablet; Oral	SUPPL-10	Aurolife Pharma Llc	Labeling	Approved
Piperacillin ANDA #065114	Piperacillin Sodium	Injectable; Injection	SUPPL-18	Istituto Bio Ita Spa	Labeling	Approved
Piperacillin ANDA #065157	Piperacillin Sodium	Injectable; Injection	SUPPL-15	Istituto Bio Ita Spa	Labeling	Approved
Piperacillin and Tazobactam ANDA #065362	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-44	Sandoz	Labeling	Approved
Piperacillin and Tazobactam ANDA #065363	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-47	Sandoz	Labeling	Approved
Piperacillin and Tazobactam ANDA #065458	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-16	Steriscience	Labeling	Approved
Piperacillin and Tazobactam ANDA #065498	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-26	Eugia Pharma Speclts	Labeling	Approved
Piperacillin and Tazobactam ANDA #065523	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-30	Istituto Bio Ita Spa	Labeling	Approved
Piperacillin and Tazobactam ANDA #090498	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-24	Istituto Bio Ita Spa	Labeling	Approved
Piperacillin and Tazobactam ANDA #203557	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-35	Sandoz	Labeling	Approved
Piperacillin and Tazobactam ANDA #203719	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-12	Fresenius Kabi	Labeling	Approved
Piperacillin and Tazobactam ANDA #203720	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-11	Fresenius Kabi	Labeling	Approved
Piperacillin and Tazobactam ANDA #204959	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-13	Shandong	Labeling	Approved
Piperacillin and Tazobactam ANDA #206996	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-9	Wockhardt Bio Ag	Labeling	Approved
Piperacillin and Tazobactam ANDA #207146	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-9	Wockhardt Bio Ag	Labeling	Approved
Piperacillin and Tazobactam ANDA #207847	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-15	Provepharm Sas	Labeling	Approved
Piperacillin and Tazobactam ANDA #207848	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-15	Provepharm Sas	Labeling	Approved
Piperacillin and Tazobactam ANDA #208674	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-5	Sagent Pharms Inc	Labeling	Approved
Piperacillin and Tazobactam ANDA #208675	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-5	Sagent Pharms Inc	Labeling	Approved
Piperacillin and Tazobactam ANDA #217243	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-4	Shandong	Labeling	Approved
Piperacillin and Tazobactam ANDA #217409	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-1	Eugia Pharma	Labeling	Approved
Piperacillin and Tazobactam ANDA #217409	Piperacillin,Tazobactam	Injection; Powder,For Solution	SUPPL-1	Eugia Pharma	Labeling	Approved
Probampacin ANDA #061741	Ampicillin/Ampicillin Trihydrate; Probenecid	For Suspension; Oral	SUPPL-1	Cosette	Labeling	Approved
Sugammadex ANDA #214230	Sugammadex	Injectable; Injection	ORIG-1	Mankind Pharma		Tentative Approval
Talicia NDA #213004	Amoxicillin; Omeprazole Magnesium; Rifabutin	Capsule, Delayed Release; Oral	SUPPL-14	Redhill	Labeling	Approved
Unasyn NDA #050608	Ampicillin Sodium; Sulbactam Sodium	Injectable; Injection	SUPPL-53	Pfizer	Labeling	Approved
Voquezna Dual Pak NDA #215153	Amoxicillin; Vonoprazan Fumarate	Capsule, Tablet; Oral	SUPPL-7	Phathom	Labeling	Approved
Voquezna Triple Pak NDA #215152	Amoxicillin; Clarithromycin; Vonoprazan Fumarate	Capsule, Tablet, Tablet; Oral	SUPPL-7	Phathom	Labeling	Approved
Zosyn NDA #050684	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-104	Wyeth Pharms	Labeling	Approved
Zosyn In Plastic Container NDA #050750	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-51	Baxter Hlthcare Corp	Labeling	Approved

April 30, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Abrilada BLA #761118	Adalimumab-Afzb	Injectable; Injection	SUPPL-12	Pfizer Inc	Labeling	Approved
Abrilada BLA #761118	Adalimumab-Afzb	Injectable; Injection	SUPPL-12	Pfizer Inc	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #090227	Amoxicillin; Clavulanate Potassium	Tablet, Extended Release; Oral	SUPPL-18	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #090227	Amoxicillin; Clavulanate Potassium	Tablet, Extended Release; Oral	SUPPL-18	Sandoz	Labeling	Approved
Aranesp BLA #103951	Darbepoetin Alfa	Vial; Intravenous	SUPPL-5383	Amgen	Labeling	Approved
Aranesp BLA #103951	Darbepoetin Alfa	Vial; Intravenous	SUPPL-5383	Amgen	Labeling	Approved
Aranesp BLA #103951	Darbepoetin Alfa	Vial; Subcutaneous	SUPPL-5383	Amgen	Labeling	Approved
Aranesp BLA #103951	Darbepoetin Alfa	Vial; Subcutaneous	SUPPL-5383	Amgen	Labeling	Approved
Bromfenac Sodium ANDA #210962	Bromfenac Sodium	Unknown	ORIG-1	Amneal Pharms Co		Tentative Approval
Camzyos NDA #214998	Mavacamten	Capsule; Oral	SUPPL-9	Bristol	Labeling	Approved
Cupric Chloride ANDA #216113	Cupric Chloride	Injectable; Injection	ORIG-1	Somerset		Approved
Cupric Chloride ANDA #217626	Cupric Chloride	Injectable; Injection	ORIG-1	Stira		Approved
Cyltezo BLA #761058	Adalimumab-Adbm	Injectable; Injection	SUPPL-26	Boehringer Ingelheim	Efficacy	Approved
Dimethyl Fumarate ANDA #210531	Dimethyl Fumarate	Capsule, Delayed Release; Oral	SUPPL-3	Mylan	Labeling	Approved
Dimethyl Fumarate ANDA #210531	Dimethyl Fumarate	Capsule, Delayed Release; Oral	SUPPL-6	Mylan	Labeling	Approved
Dimethyl Fumarate ANDA #210531	Dimethyl Fumarate	Capsule, Delayed Release; Oral	SUPPL-10	Mylan	Labeling	Approved
Dimethyl Fumarate ANDA #210531	Dimethyl Fumarate	Capsule, Delayed Release; Oral	SUPPL-12	Mylan	Labeling	Approved
Dimethyl Fumarate ANDA #210531	Dimethyl Fumarate	Capsule, Delayed Release; Oral	SUPPL-3	Mylan	Labeling	Approved
Dimethyl Fumarate ANDA #210531	Dimethyl Fumarate	Capsule, Delayed Release; Oral	SUPPL-6	Mylan	Labeling	Approved
Dimethyl Fumarate ANDA #210531	Dimethyl Fumarate	Capsule, Delayed Release; Oral	SUPPL-10	Mylan	Labeling	Approved
Dimethyl Fumarate ANDA #210531	Dimethyl Fumarate	Capsule, Delayed Release; Oral	SUPPL-12	Mylan	Labeling	Approved
Dimethyl Fumarate ANDA #210531	Dimethyl Fumarate	Capsule, Delayed Release; Oral	SUPPL-13	Mylan	Labeling	Approved
Dofetilide ANDA #212750	Dofetilide	Capsule; Oral	SUPPL-2	Granules	Labeling	Approved
Dofetilide ANDA #212750	Dofetilide	Capsule; Oral	SUPPL-2	Granules	Labeling	Approved
Dofetilide ANDA #212750	Dofetilide	Capsule; Oral	SUPPL-2	Granules	Labeling	Approved
Epogen/Procrit BLA #103234	Epoetin Alfa	Vial; Multidose	SUPPL-5378	Amgen	Labeling	Approved
Epogen/Procrit BLA #103234	Epoetin Alfa	Vial; Multidose	SUPPL-5378	Amgen	Labeling	Approved
Epogen/Procrit BLA #103234	Epoetin Alfa	Vial; Single-Use	SUPPL-5378	Amgen	Labeling	Approved
Epogen/Procrit BLA #103234	Epoetin Alfa	Vial; Single-Use	SUPPL-5378	Amgen	Labeling	Approved
Esomeprazole Magnesium ANDA #207198	Esomeprazole Magnesium	Capsule, Delayed Release; Oral	ORIG-1	Dr Reddys		Approved
Everolimus ANDA #206133	Everolimus	Tablet; Oral	SUPPL-6	Hikma	Labeling	Approved
Ezetimibe ANDA #207311	Ezetimibe	Tablet; Oral	SUPPL-12	Ohm Labs Inc	Labeling	Approved
Hydrochlorothiazide ANDA #202556	Hydrochlorothiazide	Tablet; Oral	SUPPL-8	Accord Hlthcare	Labeling	Approved
Hydrochlorothiazide ANDA #203561	Hydrochlorothiazide	Capsule; Oral	SUPPL-3	Sciegen Pharms Inc	Labeling	Approved
Hydrochlorothiazide ANDA #203561	Hydrochlorothiazide	Capsule; Oral	SUPPL-5	Sciegen Pharms Inc	Labeling	Approved
Hydrocortisone Butyrate ANDA #209556	Hydrocortisone Butyrate	Lotion; Topical	SUPPL-4	The J Molner	Labeling	Approved
Hydrocortisone Butyrate ANDA #209556	Hydrocortisone Butyrate	Lotion; Topical	SUPPL-4	The J Molner	Labeling	Approved
Ingrezza Sprinkle NDA #218390	Valbenazine	Capsule; Oral	ORIG-1	Neurocrine		Approved
Linezolid ANDA #204536	Linezolid	Tablet; Oral	SUPPL-7	Amneal Pharms	Labeling	Approved
Linezolid ANDA #204536	Linezolid	Tablet; Oral	SUPPL-8	Amneal Pharms	Labeling	Approved
Linezolid ANDA #204536	Linezolid	Tablet; Oral	SUPPL-9	Amneal Pharms	Labeling	Approved
Losartan Potassium and Hydrochlorothiazide ANDA #201845	Hydrochlorothiazide; Losartan Potassium	Tablet; Oral	SUPPL-20	Jubilant Cadista	Labeling	Approved
Losartan Potassium and Hydrochlorothiazide ANDA #201845	Hydrochlorothiazide; Losartan Potassium	Tablet; Oral	SUPPL-20	Jubilant Cadista	Labeling	Approved
Meperidine Hydrochloride ANDA #040186	Meperidine Hydrochloride	Tablet; Oral	SUPPL-13	Watson Labs	Labeling	Approved
Meperidine Hydrochloride ANDA #040186	Meperidine Hydrochloride	Tablet; Oral	SUPPL-13	Watson Labs	Labeling	Approved
Meperidine Hydrochloride ANDA #080448	Meperidine Hydrochloride	Tablet; Oral	SUPPL-23	Sun Pharm Industries	Labeling	Approved
Meperidine Hydrochloride ANDA #080448	Meperidine Hydrochloride	Tablet; Oral	SUPPL-23	Sun Pharm Industries	Labeling	Approved
Mircera BLA #125164	Methoxy Polyethylene Glycol-Epoetin Beta	Solution; Injection	SUPPL-89	Hoffman-La Roche	Efficacy	Approved
Myfembree NDA #214846	Estradiol; Norethindrone Acetate; Relugolix	Tablet; Oral	SUPPL-7	Myovant Sciences	Efficacy	Approved
Nicorette NDA #022360	Nicotine Polacrilex	Troche/Lozenge; Oral	SUPPL-17	Haleon Us Holdings	Labeling	Approved
Nicotine Polacrilex ANDA #076778	Nicotine Polacrilex	Gum, Chewing; Buccal	SUPPL-19	L Perrigo Co	Labeling	Approved
Nicotine Polacrilex ANDA #076778	Nicotine Polacrilex	Gum, Chewing; Buccal	SUPPL-19	L Perrigo Co	Labeling	Approved
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate ANDA #202742	Ethinyl Estradiol; Norethindrone Acetate	Tablet; Oral	SUPPL-10	Mylan Labs Ltd	Labeling	Approved
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate ANDA #202742	Ethinyl Estradiol; Norethindrone Acetate	Tablet; Oral	SUPPL-12	Mylan Labs Ltd	Labeling	Approved
Pitavastatin Calcium ANDA #205977	Pitavastatin Calcium	Tablet; Oral	ORIG-1	Hetero Labs Ltd V		Approved
Sevelamer Carbonate ANDA #207179	Sevelamer Carbonate	Tablet; Oral	SUPPL-11	Aurobindo Pharma	Labeling	Approved
Sotalol Hydrochloride ANDA #077616	Sotalol Hydrochloride	Tablet; Oral	SUPPL-8	Aurobindo Pharma Usa	Labeling	Approved
Sotalol Hydrochloride ANDA #077616	Sotalol Hydrochloride	Tablet; Oral	SUPPL-5	Aurobindo Pharma Usa	Labeling	Approved
Sotalol Hydrochloride ANDA #077616	Sotalol Hydrochloride	Tablet; Oral	SUPPL-8	Aurobindo Pharma Usa	Labeling	Approved
Ursodiol ANDA #075517	Ursodiol	Capsule; Oral	SUPPL-18	Epic Pharma	Labeling	Approved
Valsartan and Hydrochlorothiazide ANDA #201662	Hydrochlorothiazide; Valsartan	Tablet; Oral	SUPPL-26	Alembic	Labeling	Approved
Valsartan and Hydrochlorothiazide ANDA #201662	Hydrochlorothiazide; Valsartan	Tablet; Oral	SUPPL-26	Alembic	Labeling	Approved
Valsartan and Hydrochlorothiazide ANDA #203000	Hydrochlorothiazide; Valsartan	Tablet; Oral	SUPPL-1	Zydus Lifesciences	Labeling	Approved
Valsartan and Hydrochlorothiazide ANDA #203000	Hydrochlorothiazide; Valsartan	Tablet; Oral	SUPPL-2	Zydus Lifesciences	Labeling	Approved
Valsartan and Hydrochlorothiazide ANDA #203000	Hydrochlorothiazide; Valsartan	Tablet; Oral	SUPPL-1	Zydus Lifesciences	Labeling	Approved
Valsartan and Hydrochlorothiazide ANDA #203000	Hydrochlorothiazide; Valsartan	Tablet; Oral	SUPPL-2	Zydus Lifesciences	Labeling	Approved
Vasopressin NDA #217766	Vasopressin	Injectable; Injection	ORIG-1	Long Grove Pharms	Type 3 - New Dosage Form	Tentative Approval

April 29, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Amoxicillin and Clavulanate Potassium ANDA #065063	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-48	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065064	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-47	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065065	Amoxicillin; Clavulanate Potassium	Tablet, Chewable; Oral	SUPPL-34	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065066	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-45	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065189	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-28	Sandoz	Labeling	Approved
Atropine Sulfate ANDA #217791	Atropine Sulfate	Solution/Drops; Ophthalmic	ORIG-1	Somerset		Approved
Besremi BLA #761166	Ropeginterferon Alfa-2b-Njft	Injectable; Subcutaneous	SUPPL-7	Pharmaessentia Corp	Labeling	Approved
Colchicine ANDA #210757	Colchicine	Capsule; Oral	ORIG-1	Granules		Approved
Colchicine ANDA #215463	Colchicine	Capsule; Oral	ORIG-1	Aurobindo Pharma Ltd		Approved
Colchicine ANDA #217620	Colchicine	Capsule; Oral	ORIG-1	Annora Pharma		Approved
Ezetimibe ANDA #211159	Ezetimibe	Tablet; Oral	ORIG-1	Macleods Pharms Ltd		Approved
Givlaari NDA #212194	Givosiran Sodium	Solution; Subcutaneous	SUPPL-7	Alnylam Pharms Inc	Labeling	Approved
Lanoxin NDA #020405	Digoxin	Tablet; Oral	SUPPL-17	Concordia	Labeling	Approved
Lidocaine Hydrochloride ANDA #218411	Lidocaine Hydrochloride	Solution; Topical	ORIG-1	The J Molner		Approved
Lupkynis NDA #213716	Voclosporin	Capsule; Oral	SUPPL-4	Aurinia	Efficacy	Approved
Lupkynis NDA #213716	Voclosporin	Capsule; Oral	SUPPL-4	Aurinia	Efficacy	Approved
Lupkynis NDA #213716	Voclosporin	Capsule; Oral	SUPPL-4	Aurinia	Efficacy	Approved
Midostaurin ANDA #216076	Midostaurin	Capsule; Oral	ORIG-1	Teva Pharms		Approved
Omvoh BLA #761279	Mirikizumab-Mrkz	Injectable; Subcutaneous	SUPPL-1	Eli Lilly and Co	Labeling	Approved
Omvoh BLA #761279	Mirikizumab-Mrkz	Injectable; Subcutaneous	SUPPL-1	Eli Lilly and Co	Labeling	Approved
Omvoh BLA #761279	Mirikizumab-Mrkz	Injectable; Subcutaneous	SUPPL-1	Eli Lilly and Co	Labeling	Approved
Omvoh BLA #761279	Mirikizumab-Mrkz	Vial; Single-Use	SUPPL-1	Eli Lilly and Co	Labeling	Approved
Omvoh BLA #761279	Mirikizumab-Mrkz	Vial; Single-Use	SUPPL-1	Eli Lilly and Co	Labeling	Approved
Omvoh BLA #761279	Mirikizumab-Mrkz	Vial; Single-Use	SUPPL-1	Eli Lilly and Co	Labeling	Approved
Tagrisso NDA #208065	Osimertinib Mesylate	Tablet; Oral	SUPPL-31	Astrazeneca	Labeling	Approved
Tivdak BLA #761208	Tisotumab Vedotin-Tftv	Injectable; Injection	SUPPL-7	Seagen	Efficacy	Approved
Tretinoin ANDA #217804	Tretinoin	Cream; Topical	ORIG-1	Alembic		Approved
Truvada NDA #021752	Emtricitabine; Tenofovir Disoproxil Fumarate	Tablet; Oral	SUPPL-64	Gilead	Labeling	Approved
Truvada NDA #021752	Emtricitabine; Tenofovir Disoproxil Fumarate	Tablet; Oral	SUPPL-64	Gilead	Labeling	Approved

April 26, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Acetaminophen and Ibuprofen ANDA #218311	Acetaminophen; Ibuprofen	Tablet; Oral	ORIG-1	Glenmark Pharms Ltd		Approved
Amoxicillin and Clavulanate Potassium ANDA #065162	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-36	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065162	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-29	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065162	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-32	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065162	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-36	Teva	Labeling	Approved
Clindamycin Phosphate ANDA #064050	Clindamycin Phosphate	Solution; Topical	SUPPL-24	Padagis Us	Manufacturing (CMC)	Approved
Clindamycin Phosphate ANDA #064050	Clindamycin Phosphate	Solution; Topical	SUPPL-24	Padagis Us	Manufacturing (CMC)	Approved
Libervant NDA #218623	Diazepam	Film; Buccal	ORIG-1	Aquestive Therapeutics Inc	Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval	Approved
Rinvoq NDA #211675	Upadacitinib	Tablet, Extended Release; Oral	SUPPL-21	Abbvie	Efficacy	Approved
Rinvoq NDA #211675	Upadacitinib	Tablet, Extended Release; Oral	SUPPL-22	Abbvie	Efficacy	Approved
Rinvoq NDA #218347	Upadacitinib	Tablet, Extended Release; Oral	ORIG-1	Abbvie Inc	Type 3 - New Dosage Form	Approved
Rinvoq Lq NDA #218347	Upadacitinib	Solution; Oral	ORIG-1	Abbvie Inc	Type 3 - New Dosage Form	Approved
Xolremdi NDA #218709	Mavorixafor	Capsule; Oral	ORIG-1	X4 Pharmaceuticals Inc	Type 1 - New Molecular Entity	Approved
Zilbrysq NDA #216834	Zilucoplan Sodium	Solution; Subcutaneous	SUPPL-1	Ucb Inc	Labeling	Approved

April 25, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Amoxicillin ANDA #062881	Amoxicillin	Capsule; Oral	SUPPL-26	Strides Pharma	Labeling	Approved
Amoxicillin ANDA #062881	Amoxicillin	Capsule; Oral	SUPPL-27	Strides Pharma	Labeling	Approved
Amoxicillin ANDA #062881	Amoxicillin	Capsule; Oral	SUPPL-28	Strides Pharma	Labeling	Approved
Amoxicillin ANDA #062884	Amoxicillin	Capsule; Oral	SUPPL-24	Strides Pharma	Labeling	Approved
Amoxicillin ANDA #062884	Amoxicillin	Capsule; Oral	SUPPL-23	Strides Pharma	Labeling	Approved
Amoxicillin ANDA #062884	Amoxicillin	Capsule; Oral	SUPPL-24	Strides Pharma	Labeling	Approved
Amoxicillin ANDA #062884	Amoxicillin	Capsule; Oral	SUPPL-25	Strides Pharma	Labeling	Approved
Amoxicillin ANDA #064076	Amoxicillin	Capsule; Oral	SUPPL-37	Sandoz	Labeling	Approved
Amoxicillin ANDA #064139	Amoxicillin	Tablet, Chewable; Oral	SUPPL-13	Chartwell Rx	Labeling	Approved
Amoxicillin ANDA #064139	Amoxicillin	Tablet, Chewable; Oral	SUPPL-14	Chartwell Rx	Labeling	Approved
Amoxicillin ANDA #064139	Amoxicillin	Tablet, Chewable; Oral	SUPPL-15	Chartwell Rx	Labeling	Approved
Amoxicillin ANDA #065228	Amoxicillin	Tablet; Oral	SUPPL-17	Sandoz	Labeling	Approved
Amoxicillin ANDA #065228	Amoxicillin	Tablet; Oral	SUPPL-17	Sandoz	Labeling	Approved
Amoxicillin ANDA #065228	Amoxicillin	Tablet; Oral	SUPPL-19	Sandoz	Labeling	Approved
Amoxicillin ANDA #065255	Amoxicillin	Tablet; Oral	SUPPL-25	Hikma	Labeling	Approved
Amoxicillin ANDA #065325	Amoxicillin	For Suspension; Oral	SUPPL-32	Hikma	Labeling	Approved
Amoxicillin ANDA #065344	Amoxicillin	Tablet; Oral	SUPPL-5	Chartwell Rx	Labeling	Approved
Amoxicillin ANDA #065344	Amoxicillin	Tablet; Oral	SUPPL-6	Chartwell Rx	Labeling	Approved
Amoxicillin ANDA #065344	Amoxicillin	Tablet; Oral	SUPPL-7	Chartwell Rx	Labeling	Approved
Amoxicillin ANDA #065378	Amoxicillin	For Suspension; Oral	SUPPL-18	Sandoz	Labeling	Approved
Amoxicillin ANDA #065387	Amoxicillin	For Suspension; Oral	SUPPL-18	Sandoz	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #201090	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-11	Aurobindo Pharma Ltd	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #201090	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-5	Aurobindo Pharma Ltd	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #201090	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-11	Aurobindo Pharma Ltd	Labeling	Approved
Amrix NDA #021777	Cyclobenzaprine Hydrochloride	Capsule, Extended Release; Oral	SUPPL-19	Teva Pharms Intl	Labeling	Approved
Brinzolamide ANDA #204884	Brinzolamide	Suspension/Drops; Ophthalmic	SUPPL-7	Bausch and Lomb	Labeling	Approved
Cetrorelix Acetate ANDA #218150	Cetrorelix Acetate	Powder; Subcutaneous	ORIG-1	Gland		Approved
Deflazacort ANDA #217813	Deflazacort	Suspension; Oral	ORIG-1	Tris Pharma Inc		Approved
Diazepam ANDA #218450	Diazepam	Injectable; Injection	ORIG-1	Alembic		Approved
Digoxin NDA #021648	Digoxin	Elixir; Oral	SUPPL-15	Hikma	Labeling	Approved
Digoxin NDA #021648	Digoxin	Elixir; Oral	SUPPL-15	Hikma	Labeling	Approved
Eslicarbazepine Acetate ANDA #211247	Eslicarbazepine Acetate	Unknown	ORIG-1	Sph Shanghai Zhongxi Pharma Co Ltd		Tentative Approval
Galzin NDA #020458	Zinc Acetate	Capsule; Oral	SUPPL-9	Teva	Labeling	Approved
Hercessi BLA #761346	Trastuzumab-Strf	Injectable; Injection	ORIG-1	Accord Biopharma Inc.		Approved
Otezla NDA #205437	Apremilast	Tablet; Oral	SUPPL-13	Amgen Inc	Efficacy	Approved
Safinamide Mesylate ANDA #215739	Safinamide Mesylate	Tablet; Oral	ORIG-1	Prinston Inc		Approved
Sevelamer Carbonate ANDA #207291	Sevelamer Carbonate	For Suspension; Oral	ORIG-1	Macleods Pharms Ltd		Approved
Trandate NDA #018716	Labetalol Hydrochloride	Tablet; Oral	SUPPL-36	Alvogen	Labeling	Approved
Tretinoin ANDA #218561	Tretinoin	Cream; Topical	ORIG-1	Zydus Lifesciences		Approved
Viorele ANDA #091346	Desogestrel; Ethinyl Estradiol	Tablet; Oral-28	SUPPL-16	Glenmark Pharms Ltd	Manufacturing (CMC)	Approved
Zinc Chloride In Plastic Container NDA #018959	Zinc Chloride	Injectable; Injection	SUPPL-32	Hospira	Labeling	Approved

April 24, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Amoxicillin and Clavulanate Potassium ANDA #065089	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-26	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065089	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-21	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065089	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-26	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065096	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-36	Teva Pharms Usa	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065096	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-33	Teva Pharms Usa	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065096	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-36	Teva Pharms Usa	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065101	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-35	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065101	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-32	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065101	Amoxicillin; Clavulanate Potassium	Tablet; Oral	SUPPL-35	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065205	Amoxicillin; Clavulanate Potassium	Tablet, Chewable; Oral	SUPPL-26	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065205	Amoxicillin; Clavulanate Potassium	Tablet, Chewable; Oral	SUPPL-19	Teva	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065205	Amoxicillin; Clavulanate Potassium	Tablet, Chewable; Oral	SUPPL-26	Teva	Labeling	Approved
Ampicillin Sodium ANDA #065499	Ampicillin Sodium	Injectable; Injection	SUPPL-11	Eugia Pharma Speclts	Labeling	Approved
Ampicillin Trihydrate ANDA #061502	Ampicillin/Ampicillin Trihydrate	Capsule; Oral	SUPPL-138	Chartwell Rx	Labeling	Approved
Ampicillin Trihydrate ANDA #061502	Ampicillin/Ampicillin Trihydrate	Capsule; Oral	SUPPL-139	Chartwell Rx	Labeling	Approved
Biktarvy NDA #210251	Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate	Tablet; Oral	SUPPL-19	Gilead Sciences Inc	Efficacy	Approved
Cetrorelix Acetate ANDA #214540	Cetrorelix Acetate	Powder; Subcutaneous	ORIG-1	Livzon Grp		Approved
Clinolipid 20% NDA #204508	Olive Oil; Soybean Oil	Emulsion; Intravenous	SUPPL-22	Baxter Hlthcare Corp	Efficacy	Approved
Fenofibrate ANDA #218548	Fenofibrate	Tablet; Oral	ORIG-1	Yichang Humanwell		Approved
Lacosamide ANDA #214695	Lacosamide	Tablet; Oral	SUPPL-2	Alkem Labs Ltd	Labeling	Approved
Lacosamide ANDA #214695	Lacosamide	Tablet; Oral	SUPPL-4	Alkem Labs Ltd	Labeling	Approved
Lacosamide ANDA #214695	Lacosamide	Tablet; Oral	SUPPL-7	Alkem Labs Ltd	Labeling	Approved
Lacosamide ANDA #214695	Lacosamide	Tablet; Oral	SUPPL-2	Alkem Labs Ltd	Labeling	Approved
Lacosamide ANDA #214695	Lacosamide	Tablet; Oral	SUPPL-4	Alkem Labs Ltd	Labeling	Approved
Lacosamide ANDA #214695	Lacosamide	Tablet; Oral	SUPPL-6	Alkem Labs Ltd	Labeling	Approved
Lacosamide ANDA #214695	Lacosamide	Tablet; Oral	SUPPL-7	Alkem Labs Ltd	Labeling	Approved
Loteprednol Etabonate ANDA #215719	Loteprednol Etabonate	Suspension/Drops; Ophthalmic	ORIG-1	Lupin Ltd		Approved
Norethindrone Acetate and Ethinyl Estradiol ANDA #202770	Ethinyl Estradiol; Norethindrone Acetate	Tablet; Oral-21	SUPPL-9	Mylan Labs Ltd	Labeling	Approved
Norethindrone Acetate and Ethinyl Estradiol ANDA #202770	Ethinyl Estradiol; Norethindrone Acetate	Tablet; Oral-21	SUPPL-7	Mylan Labs Ltd	Labeling	Approved
Norethindrone Acetate and Ethinyl Estradiol ANDA #202770	Ethinyl Estradiol; Norethindrone Acetate	Tablet; Oral-21	SUPPL-9	Mylan Labs Ltd	Labeling	Approved
Nortriptyline Hydrochloride ANDA #074132	Nortriptyline Hydrochloride	Capsule; Oral	SUPPL-31	Teva	Labeling	Approved
Nortriptyline Hydrochloride ANDA #074132	Nortriptyline Hydrochloride	Capsule; Oral	SUPPL-31	Teva	Labeling	Approved
Nortriptyline Hydrochloride ANDA #074132	Nortriptyline Hydrochloride	Capsule; Oral	SUPPL-31	Teva	Labeling	Approved
Piperacillin and Tazobactam ANDA #065363	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-39	Sandoz	Labeling	Approved
Piperacillin and Tazobactam ANDA #065363	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-39	Sandoz	Labeling	Approved
Piperacillin and Tazobactam ANDA #065363	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-40	Sandoz	Labeling	Approved
Piperacillin and Tazobactam ANDA #065363	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-39	Sandoz	Labeling	Approved
Pivya NDA #216483	Amdinocillin Pivoxil	Tablet; Oral	ORIG-1	Utility Therapeutics Ltd	Type 2 - New Active Ingredient	Approved
Vijoice NDA #215039	Alpelisib	Tablet; Oral	SUPPL-2	Novartis	Efficacy	Approved
Vijoice NDA #218466	Alpelisib	Granules; Oral	ORIG-1	Novartis Pharms Corp	Type 3 - New Dosage Form	Approved
Vijoice NDA #218466	Alpelisib	Tablet; Oral	ORIG-1	Novartis Pharms Corp	Type 3 - New Dosage Form	Approved

April 23, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Amoxicillin ANDA #062927	Amoxicillin	For Suspension; Oral	SUPPL-26	Dava Pharms Inc	Labeling	Approved
Amoxicillin ANDA #062927	Amoxicillin	For Suspension; Oral	SUPPL-27	Dava Pharms Inc	Labeling	Approved
Amoxicillin ANDA #062927	Amoxicillin	For Suspension; Oral	SUPPL-28	Dava Pharms Inc	Labeling	Approved
Amoxicillin and Clavulanate Potassium ANDA #065191	Amoxicillin; Clavulanate Potassium	For Suspension; Oral	SUPPL-32	Hikma Pharms	Labeling	Approved
Atorvaliq NDA #213260	Atorvastatin Calcium	Suspension; Oral	SUPPL-2	Cmp Dev Llc	Labeling	Approved
Cambia NDA #022165	Diclofenac Potassium	For Solution; Oral	SUPPL-6	Assertio	Labeling	Approved
Gleolan NDA #208630	Aminolevulinic Acid Hydrochloride	For Solution; Oral	SUPPL-7	Nxdc	Labeling	Approved
Levetiracetam ANDA #091261	Levetiracetam	Tablet, Extended Release; Oral	SUPPL-15	Apotex Inc	Labeling	Approved
Levetiracetam ANDA #202958	Levetiracetam	Tablet, Extended Release; Oral	SUPPL-7	Apotex	Labeling	Approved
Lutathera NDA #208700	Lutetium Lu 177 Dotatate	Solution; Intravenous	SUPPL-31	Aaa Usa Inc	Efficacy	Approved
Mometasone Furoate ANDA #217438	Mometasone Furoate	Spray, Metered; Nasal	ORIG-1	Apotex		Approved
Naloxone Hydrochloride ANDA #217992	Naloxone Hydrochloride	Spray, Metered; Nasal	ORIG-1	Amneal		Approved
Ojemda NDA #217700	Tovorafenib	Suspension; Oral	ORIG-1	Day One Biopharmaceuticals Inc	Type 1 - New Molecular Entity	Approved
Ojemda NDA #217700	Tovorafenib	Tablet; Oral	ORIG-1	Day One Biopharmaceuticals Inc	Type 1 - New Molecular Entity	Approved
Ojemda NDA #218033	Tovorafenib	Suspension; Oral	ORIG-1	Day One Biopharmaceuticals Inc	Type 1 - New Molecular Entity	Approved
Ojemda NDA #218033	Tovorafenib	Tablet; Oral	ORIG-1	Day One Biopharmaceuticals Inc	Type 1 - New Molecular Entity	Approved
Pantoprazole Sodium ANDA #217416	Pantoprazole Sodium	For Suspension, Delayed Release; Oral	SUPPL-2	Ajanta Pharma Ltd	Labeling	Approved
Pazopanib Hydrochloride ANDA #218231	Pazopanib Hydrochloride	Tablet; Oral	ORIG-1	Novugen		Approved
Rabeprazole Sodium ANDA #202376	Rabeprazole Sodium	Tablet, Delayed Release; Oral	SUPPL-20	Torrent	Labeling	Approved
Rabeprazole Sodium ANDA #202376	Rabeprazole Sodium	Tablet, Delayed Release; Oral	SUPPL-20	Torrent	Labeling	Approved
Verapamil Hydrochloride ANDA #216471	Verapamil Hydrochloride	Injectable; Injection	ORIG-1	Fresenius Kabi Usa		Approved

April 22, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Anktiva BLA #761336	Nogapendekin Alfa Inbakicept-Pmln	Solution; Intravesical	ORIG-1	Altor Bioscience, Llc, An Indirect Wholly-Owned Su	Type 1 - New Molecular Entity	Approved
Enzalutamide ANDA #218187	Enzalutamide	Tablet; Oral	ORIG-1	Teva Pharms Inc		Tentative Approval
Estradiol ANDA #216160	Estradiol	Gel, Metered; Transdermal	ORIG-1	Solaris Pharma Corp		Approved
Extraneal NDA #021321	Icodextrin	Solution; Intraperitoneal	SUPPL-38	Baxter Hlthcare	Labeling	Approved
Imfinzi BLA #761069	Durvalumab	Injectable; Injection	SUPPL-48	Astrazeneca Uk Ltd	Labeling	Approved
Loqtorzi BLA #761240	Toripalimab-Tpzi	Injectable; Injection	SUPPL-1	Coherus Biosciences Inc	Labeling	Approved
Minoxidil (For Men) ANDA #218616	Minoxidil	Aerosol, Foam; Topical	ORIG-1	Aurobindo Pharma		Approved
Minoxidil (For Women) ANDA #218616	Minoxidil	Aerosol, Foam; Topical	ORIG-1	Aurobindo Pharma		Approved
Tecentriq BLA #761034	Atezolizumab	Injectable; Injection	SUPPL-53	Genentech Inc	Labeling	Approved
Zynyz BLA #761334	Retifanlimab-Dlwr	Injectable; Intravenous	SUPPL-2	Incyte Corp	Labeling	Approved