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.
May 30, 2023
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Fintepla
NDA #212102 |
Fenfluramine Hydrochloride | Solution; Oral | SUPPL-9 | Zogenix Inc | REMS | Approved |
| Obeticholic Acid
ANDA #214862 |
Obeticholic Acid | Tablet; Oral | ORIG-1 | Apotex Inc | Approved | |
| Obeticholic Acid
ANDA #214980 |
Obeticholic Acid | Tablet; Oral | ORIG-1 | Lupin Ltd | Approved | |
| Semglee
BLA #761201 |
Insulin Glargine-Yfgn | Injectable; Injection | SUPPL-7 | Mylan Pharms Inc | Labeling | Approved |
| Vevye
NDA #217469 |
Cyclosporine | Solution; Ophthalmic | ORIG-1 | Novaliq Gmbh | Type 5 - New Formulation or New Manufacturer | Approved |
May 28, 2023
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Albuterol Sulfate
ANDA #207857 |
Albuterol Sulfate | Solution; Inhalation | SUPPL-8 | Sun Pharm | Labeling | Approved |
| Albuterol Sulfate
ANDA #207857 |
Albuterol Sulfate | Solution; Inhalation | SUPPL-8 | Sun Pharm | Labeling | Approved |
| Azithromycin
ANDA #065246 |
Azithromycin | For Suspension; Oral | SUPPL-30 | Pliva | Labeling | Approved |
| Azithromycin
ANDA #065246 |
Azithromycin | For Suspension; Oral | SUPPL-30 | Pliva | Labeling | Approved |
May 26, 2023
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Apixaban
ANDA #210026 |
Apixaban | Tablet; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Dolutegravir, Emtricitabine and Tenofovir Alafenamide
NDA #215448 |
Dolutegravir, Emtricitabine and Tenofovir Alafenamide | Tablet; Oral | ORIG-1 | Aurobindo Pharma Usa | Type 4 - New Combination | Tentative Approval |
| Inpefa
NDA #216203 |
Sotagliflozin | Tablet; Oral | ORIG-1 | Lexicon Pharmaceuticals Inc | Type 1 - New Molecular Entity | Approved |
| Itraconazole
ANDA #076104 |
Itraconazole | Capsule; Oral | SUPPL-24 | Sandoz | Labeling | Approved |
| Itraconazole
ANDA #076104 |
Itraconazole | Capsule; Oral | SUPPL-24 | Sandoz | Labeling | Approved |
| Itraconazole
ANDA #205724 |
Itraconazole | Capsule; Oral | SUPPL-5 | Par Pharm Inc | Labeling | Approved |
| Itraconazole
ANDA #209460 |
Itraconazole | Capsule; Oral | SUPPL-4 | Torrent | Labeling | Approved |
| Itraconazole
ANDA #209460 |
Itraconazole | Capsule; Oral | SUPPL-4 | Torrent | Labeling | Approved |
| Itraconazole
ANDA #212239 |
Itraconazole | Solution; Oral | SUPPL-1 | Annora Pharma | Labeling | Approved |
| Mekinist
NDA #204114 |
Trametinib Dimethyl Sulfoxide | Tablet; Oral | SUPPL-28 | Novartis | Labeling | Approved |
| Metformin Hydrochloride
ANDA #213320 |
Metformin Hydrochloride | Tablet; Oral | SUPPL-2 | Harman Finochem | Manufacturing (CMC) | Approved |
| Opsumit
NDA #204410 |
Macitentan | Tablet; Oral | SUPPL-24 | Actelion | Labeling | Approved |
| Pramipexole Dihydrochloride
ANDA #212797 |
Pramipexole Dihydrochloride | Tablet, Extended Release; Oral | SUPPL-1 | Xiamen Lp Pharm Co | Labeling | Approved |
| Pramipexole Dihydrochloride
ANDA #212797 |
Pramipexole Dihydrochloride | Tablet, Extended Release; Oral | SUPPL-1 | Xiamen Lp Pharm Co | Labeling | Approved |
| Sevelamer Hydrochloride
ANDA #206883 |
Sevelamer Hydrochloride | Tablet; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Tafinlar
NDA #202806 |
Dabrafenib Mesylate | Capsule; Oral | SUPPL-26 | Novartis | Labeling | Approved |
| Tezspire
BLA #761224 |
Tezepelumab-Ekko | Solution; Subcutaneous | SUPPL-3 | Astrazeneca Ab | Labeling | Approved |
| Timolol Maleate
ANDA #217343 |
Timolol Maleate | Solution/Drops; Ophthalmic | ORIG-1 | Micro Labs | Approved | |
| Vasopressin
ANDA #213205 |
Vasopressin | Injectable; Injection | ORIG-1 | Fresenius Kabi Usa | Tentative Approval | |
| Vasopressin
ANDA #213206 |
Vasopressin | Solution; Intravenous | ORIG-1 | Fresenius Kabi Usa | Approved | |
| Zinplava
BLA #761046 |
Bezlotoxumab | Injectable; Injection | SUPPL-12 | Merck Sharp Dohme | Efficacy | Approved |
May 25, 2023
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #203136 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-44 | Amneal Pharms | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #214930 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-9 | Alkem Labs Ltd | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #214930 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-9 | Alkem Labs Ltd | Labeling | Approved |
| Carboprost Tromethamine
ANDA #216939 |
Carboprost Tromethamine | Injectable; Injection | ORIG-1 | Eugia Pharma | Approved | |
| Chlordiazepoxide Hydrochloride and Clidinium Bromide
ANDA #214065 |
Chlordiazepoxide Hydrochloride; Clidinium Bromide | Capsule; Oral | SUPPL-5 | Alkem Labs Ltd | Labeling | Approved |
| Claritin Hives Relief Reditab
NDA #020704 |
Loratadine | Tablet, Orally Disintegrating; Oral | SUPPL-41 | Bayer Healthcare Llc | Labeling | Approved |
| Claritin Reditabs
NDA #020704 |
Loratadine | Tablet, Orally Disintegrating; Oral | SUPPL-41 | Bayer Healthcare Llc | Labeling | Approved |
| Claritin Reditabs
NDA #021993 |
Loratadine | Tablet, Orally Disintegrating; Oral | SUPPL-23 | Bayer Healthcare Llc | Labeling | Approved |
| Eptifibatide
ANDA #206127 |
Eptifibatide | Injectable; Injection | SUPPL-4 | Eugia Pharma | Labeling | Approved |
| Margenza
BLA #761150 |
Margetuximab-Cmkb | Injectable; Injection | SUPPL-5 | Macrogenics Inc | Efficacy | Approved |
| Nitisinone
ANDA #216201 |
Nitisinone | Capsule; Oral | ORIG-1 | Zenara | Approved | |
| Palonosetron Hydrochloride
ANDA #205870 |
Palonosetron Hydrochloride | Injectable; Intravenous | SUPPL-3 | Sagent Pharms Inc | Labeling | Approved |
| Paxlovid
NDA #217188 |
Ritonavir, Nirmatrelvir | Tablet; Oral | ORIG-1 | Pfizer Inc | Type 1 - New Molecular Entity | Approved |
| Posluma
NDA #216023 |
Flotufolastat F-18 | Injectable; Intravenous | ORIG-1 | Blue Earth Diagnostics Ltd. | Type 1 - New Molecular Entity | Approved |
| Sustol
NDA #022445 |
Granisetron | Injection, Extended Release; Subcutaneous | SUPPL-10 | Heron Theraps Inc | Labeling | Approved |
| Sustol
NDA #022445 |
Granisetron | Injection, Extended Release; Subcutaneous | SUPPL-10 | Heron Theraps Inc | Labeling | Approved |
| Topiramate
ANDA #078235 |
Topiramate | Tablet; Oral | SUPPL-32 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate
ANDA #078235 |
Topiramate | Tablet; Oral | SUPPL-33 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate
ANDA #078235 |
Topiramate | Tablet; Oral | SUPPL-32 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate
ANDA #078235 |
Topiramate | Tablet; Oral | SUPPL-33 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate
ANDA #078877 |
Topiramate | Capsule; Oral | SUPPL-22 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate
ANDA #078877 |
Topiramate | Capsule; Oral | SUPPL-24 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate
ANDA #078877 |
Topiramate | Capsule; Oral | SUPPL-22 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate
ANDA #078877 |
Topiramate | Capsule; Oral | SUPPL-24 | Zydus Pharms Usa Inc | Labeling | Approved |
| Triazolam
ANDA #213003 |
Triazolam | Tablet; Oral | SUPPL-1 | Zydus Pharms | Labeling | Approved |
| Triazolam
ANDA #213003 |
Triazolam | Tablet; Oral | SUPPL-1 | Zydus Pharms | Labeling | Approved |
| Ultravist (Pharmacy Bulk)
NDA #021425 |
Iopromide | Injectable; Injection | SUPPL-36 | Bayer Hlthcare | Efficacy | Approved |
| Ultravist 150
NDA #020220 |
Iopromide | Injectable; Injection | SUPPL-54 | Bayer Hlthcare | Efficacy | Approved |
| Ultravist 240
NDA #020220 |
Iopromide | Injectable; Injection | SUPPL-54 | Bayer Hlthcare | Efficacy | Approved |
| Ultravist 300
NDA #020220 |
Iopromide | Injectable; Injection | SUPPL-54 | Bayer Hlthcare | Efficacy | Approved |
| Ultravist 300 In Plastic Container
NDA #020220 |
Iopromide | Injectable; Injection | SUPPL-54 | Bayer Hlthcare | Efficacy | Approved |
| Ultravist 370
NDA #020220 |
Iopromide | Injectable; Injection | SUPPL-54 | Bayer Hlthcare | Efficacy | Approved |
May 24, 2023
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acetazolamide
ANDA #205530 |
Acetazolamide | Tablet; Oral | SUPPL-11 | Heritage Pharma | Labeling | Approved |
| Dextromethorphan Hydrobromide and Quinidine Sulfate
ANDA #202934 |
Dextromethorphan Hydrobromide; Quinidine Sulfate | Capsule; Oral | SUPPL-1 | Actavis Elizabeth | Labeling | Approved |
| Imipramine Hydrochloride
ANDA #083745 |
Imipramine Hydrochloride | Tablet; Oral | SUPPL-123 | Sandoz | Labeling | Approved |
| Imipramine Hydrochloride
ANDA #083745 |
Imipramine Hydrochloride | Tablet; Oral | SUPPL-123 | Sandoz | Labeling | Approved |
| Imipramine Hydrochloride
ANDA #084936 |
Imipramine Hydrochloride | Tablet; Oral | SUPPL-109 | Sandoz | Labeling | Approved |
| Imipramine Hydrochloride
ANDA #084936 |
Imipramine Hydrochloride | Tablet; Oral | SUPPL-109 | Sandoz | Labeling | Approved |
| Imipramine Hydrochloride
ANDA #084937 |
Imipramine Hydrochloride | Tablet; Oral | SUPPL-129 | Sandoz | Labeling | Approved |
| Imipramine Hydrochloride
ANDA #084937 |
Imipramine Hydrochloride | Tablet; Oral | SUPPL-129 | Sandoz | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #216266 |
Lisdexamfetamine Dimesylate | Capsule; Oral | ORIG-1 | Prinston Pharma Inc | Tentative Approval | |
| Lumizyme
BLA #125291 |
Alglucosidase Alfa | Powder; Iv (Infusion) | SUPPL-159 | Genzyme | Labeling | Approved |
| Methimazole
ANDA #209827 |
Methimazole | Tablet; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Metronidazole In Plastic Container
ANDA #217665 |
Metronidazole In Plastic Container | Injectable; Injection | ORIG-1 | Amneal | Approved | |
| Nasonex 24hr Allergy
NDA #215712 |
Mometasone Furoate | Spray, Metered; Nasal | SUPPL-15 | Perrigo Pharma Intl | Labeling | Approved |
| Norethindrone
ANDA #091209 |
Norethindrone | Tablet; Oral-28 | SUPPL-10 | Glenmark Generics | Labeling | Approved |
| Norethindrone
ANDA #091209 |
Norethindrone | Tablet; Oral-28 | SUPPL-10 | Glenmark Generics | Labeling | Approved |
| Ondansetron Hydrochloride
ANDA #206846 |
Ondansetron Hydrochloride | Injectable; Injection | SUPPL-8 | Accord Hlthcare | Labeling | Approved |
| Ondansetron Hydrochloride Preservative Free
ANDA #206845 |
Ondansetron Hydrochloride | Injectable; Injection | SUPPL-8 | Accord Hlthcare | Labeling | Approved |
| Oxybutynin Chloride
ANDA #206121 |
Oxybutynin Chloride | Tablet, Extended Release; Oral | SUPPL-6 | Unique | Labeling | Approved |
| Pazopanib
ANDA #215837 |
Pazopanib | Tablet; Oral | ORIG-1 | Sun Pharm Inds Ltd | Tentative Approval | |
| Readyprep Chg
NDA #207964 |
Chlorhexidine Gluconate | Cloth; Topical | SUPPL-3 | Medline Industries | Manufacturing (CMC) | Approved |
| Risedronate Sodium
ANDA #079215 |
Risedronate Sodium | Tablet; Oral | SUPPL-4 | Teva Pharms Usa | Labeling | Approved |
| Risedronate Sodium
ANDA #079215 |
Risedronate Sodium | Tablet; Oral | SUPPL-4 | Teva Pharms Usa | Labeling | Approved |
| Rocuronium Bromide
ANDA #217034 |
Rocuronium Bromide | Injectable; Injection | ORIG-1 | Hikma | Approved | |
| Tofacitinib
ANDA #216940 |
Tofacitinib | Tablet; Oral | ORIG-1 | Heilongjiang Zbd Pharmaceutical Co Ltd | Tentative Approval | |
| Venlafaxine Hydrochloride
ANDA #214419 |
Venlafaxine Hydrochloride | Tablet, Extended Release; Oral | SUPPL-1 | Ascent Pharms Inc | Labeling | Approved |
| Venlafaxine Hydrochloride
ANDA #214419 |
Venlafaxine Hydrochloride | Tablet, Extended Release; Oral | SUPPL-1 | Ascent Pharms Inc | Labeling | Approved |
May 23, 2023
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Baclofen
ANDA #090334 |
Baclofen | Tablet; Oral | SUPPL-3 | Appco | Labeling | Approved |
| Brixadi
NDA #210136 |
Buprenorphine | Injection, Extended Release; Subcutaneous | ORIG-1 | Braeburn Pharma Inc | Type 3 - New Dosage Form | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Film; Buccal, Sublingual | SUPPL-23 | Alvogen | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Film; Buccal, Sublingual | SUPPL-15 | Alvogen | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Film; Buccal, Sublingual | SUPPL-21 | Alvogen | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Film; Buccal, Sublingual | SUPPL-15 | Alvogen | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Film; Buccal, Sublingual | SUPPL-21 | Alvogen | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Film; Buccal, Sublingual | SUPPL-23 | Alvogen | Labeling | Approved |
| Chorionic Gonadotropin
BLA #017016 |
Gonadotropin, Chorionic | Injectable; Injection | SUPPL-172 | Ferring | Labeling | Approved |
| Divigel
NDA #022038 |
Estradiol | Gel; Transdermal | SUPPL-10 | Vertical Pharms | Labeling | Approved |
| Exemestane
ANDA #200898 |
Exemestane | Tablet; Oral | SUPPL-12 | Alvogen | Labeling | Approved |
| Fexofenadine Hydrochloride
ANDA #213466 |
Fexofenadine Hydrochloride | Suspension; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-4 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-5 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-8 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-9 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-10 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-11 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-4 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-6 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-8 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-9 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-10 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-11 | Mylan Pharms Inc | Labeling | Approved |
| Haloperidol Decanoate
ANDA #216730 |
Haloperidol Decanoate | Injectable; Injection | ORIG-1 | Mankind Pharma | Approved | |
| Levetiracetam In Sodium Chloride
ANDA #206880 |
Levetiracetam | Injectable; Intravenous | SUPPL-7 | Gland Pharma Ltd | Labeling | Approved |
| Levetiracetam In Sodium Chloride
ANDA #207160 |
Levetiracetam | Injectable; Intravenous | SUPPL-5 | Eugia Pharma | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #214447 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
ANDA #203580 |
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil | Tablet; Oral | SUPPL-18 | Torrent | Labeling | Approved |
| Posaconazole
ANDA #214842 |
Posaconazole | Injectable; Injection | ORIG-1 | Eugia Pharma Speclts | Tentative Approval | |
| Regadenoson
ANDA #217455 |
Regadenoson | Solution; Intravenous | ORIG-1 | Baxter Hlthcare Corp | Approved | |
| Ropivacaine Hydrochloride
ANDA #090194 |
Ropivacaine Hydrochloride | Solution; Injection | SUPPL-2 | Hospira | Labeling | Approved |
| Ropivacaine Hydrochloride
ANDA #090194 |
Ropivacaine Hydrochloride | Solution; Injection | SUPPL-5 | Hospira | Labeling | Approved |
| Simvastatin
ANDA #090383 |
Simvastatin | Tablet; Oral | SUPPL-13 | Micro Labs | Labeling | Approved |
| Simvastatin
ANDA #090383 |
Simvastatin | Tablet; Oral | SUPPL-12 | Micro Labs | Labeling | Approved |
| Simvastatin
ANDA #090383 |
Simvastatin | Tablet; Oral | SUPPL-13 | Micro Labs | Labeling | Approved |
| Simvastatin
ANDA #090383 |
Simvastatin | Tablet; Oral | SUPPL-14 | Micro Labs | Labeling | Approved |
| Simvastatin
ANDA #090383 |
Simvastatin | Tablet; Oral | SUPPL-15 | Micro Labs | Labeling | Approved |
| Simvastatin
ANDA #090383 |
Simvastatin | Tablet; Oral | SUPPL-15 | Micro Labs | Labeling | Approved |
| Tofacitinib
ANDA #216770 |
Tofacitinib | Tablet; Oral | ORIG-1 | Teva Pharms Inc | Tentative Approval | |
| Xacduro
NDA #216974 |
Sulbactam;Durlobactam | Injectable; Injection | ORIG-1 | Entasis Therapeutics Inc | Type 1 - New Molecular Entity and Type 4 - New Combination | Approved |
| Yuflyma
BLA #761219 |
Adalimumab-Aaty | Injectable; Injection | ORIG-1 | Celltrion | Type 2 - New Active Ingredient | Approved |
| Zolmitriptan
ANDA #202279 |
Zolmitriptan | Tablet; Oral | SUPPL-5 | Jubilant Generics | Labeling | Approved |
May 22, 2023
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Ayvakit
NDA #212608 |
Avapritinib | Tablet; Oral | SUPPL-13 | Blueprint Medicines | Efficacy | Approved |
| Clobazam
ANDA #209718 |
Clobazam | Tablet; Oral | SUPPL-4 | Amneal Pharms Co | Labeling | Approved |
| Clobazam
ANDA #209718 |
Clobazam | Tablet; Oral | SUPPL-4 | Amneal Pharms Co | Labeling | Approved |
| Clobazam
ANDA #209718 |
Clobazam | Tablet; Oral | SUPPL-9 | Amneal Pharms Co | Labeling | Approved |
| Clobazam
ANDA #209718 |
Clobazam | Tablet; Oral | SUPPL-4 | Amneal Pharms Co | Labeling | Approved |
| Clobazam
ANDA #209718 |
Clobazam | Tablet; Oral | SUPPL-9 | Amneal Pharms Co | Labeling | Approved |
| Clobazam
ANDA #210746 |
Clobazam | Suspension; Oral | SUPPL-7 | Vistapharm | Labeling | Approved |
| Clobazam
ANDA #210746 |
Clobazam | Suspension; Oral | SUPPL-7 | Vistapharm | Labeling | Approved |
| Clobazam
ANDA #210978 |
Clobazam | Suspension; Oral | SUPPL-6 | Taro | Labeling | Approved |
| Clobazam
ANDA #210978 |
Clobazam | Suspension; Oral | SUPPL-6 | Taro | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209647 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-5 | Amneal Pharms Ny | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209647 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-4 | Amneal Pharms Ny | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209647 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-5 | Amneal Pharms Ny | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209647 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-7 | Amneal Pharms Ny | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209647 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-4 | Amneal Pharms Ny | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209647 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-5 | Amneal Pharms Ny | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209647 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-7 | Amneal Pharms Ny | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209735 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-9 | Sun Pharm | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209735 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-11 | Sun Pharm | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209735 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-13 | Sun Pharm | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209735 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-9 | Sun Pharm | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209735 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-11 | Sun Pharm | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209735 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-13 | Sun Pharm | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #210559 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-6 | Indchemie Health | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #210559 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-3 | Indchemie Health | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #210559 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-6 | Indchemie Health | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #210559 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-3 | Indchemie Health | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #210559 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-6 | Indchemie Health | Labeling | Approved |
| Hydromorphone Hydrochloride
ANDA #204278 |
Hydromorphone Hydrochloride | Tablet, Extended Release; Oral | SUPPL-17 | Padagis Us | Labeling | Approved |
| Hydromorphone Hydrochloride
ANDA #204278 |
Hydromorphone Hydrochloride | Tablet, Extended Release; Oral | SUPPL-17 | Padagis Us | Labeling | Approved |
| Hydromorphone Hydrochloride
ANDA #204278 |
Hydromorphone Hydrochloride | Tablet, Extended Release; Oral | SUPPL-17 | Padagis Us | Labeling | Approved |
| Itraconazole
ANDA #206741 |
Itraconazole | Capsule; Oral | SUPPL-14 | Alembic | Labeling | Approved |
| Itraconazole
ANDA #206741 |
Itraconazole | Capsule; Oral | SUPPL-14 | Alembic | Labeling | Approved |
| Itraconazole
ANDA #206741 |
Itraconazole | Capsule; Oral | SUPPL-14 | Alembic | Labeling | Approved |
| Levetiracetam
ANDA #201157 |
Levetiracetam | Solution; Oral | SUPPL-8 | Pharm Assoc | Labeling | Approved |
| Levetiracetam
ANDA #204312 |
Levetiracetam | Injectable; Intravenous | SUPPL-9 | Eugia Pharma | Labeling | Approved |
| Levetiracetam
ANDA #211954 |
Levetiracetam | Injectable; Intravenous | SUPPL-2 | Micro Labs | Labeling | Approved |
| Levetiracetam
ANDA #211954 |
Levetiracetam | Injectable; Intravenous | SUPPL-1 | Micro Labs | Labeling | Approved |
| Levetiracetam
ANDA #211954 |
Levetiracetam | Injectable; Intravenous | SUPPL-2 | Micro Labs | Labeling | Approved |
| Levoleucovorin Calcium
ANDA #217314 |
Levoleucovorin Calcium | Solution; Intravenous | ORIG-1 | Hainan Poly Pharm | Approved | |
| Opvee
NDA #217470 |
Nalmefene | Spray; Nasal | ORIG-1 | Opiant Pharmaceuticals Inc | Type 3 - New Dosage Form | Approved |
| Pemetrexed
NDA #215179 |
Pemetrexed | Solution; Intravenous | ORIG-1 | Shilpa Medicare Ltd | Type 5 - New Formulation or New Manufacturer | Approved |
| Rydapt
NDA #207997 |
Midostaurin | Capsule; Oral | SUPPL-10 | Novartis | Labeling | Approved |
| Vigabatrin
ANDA #214961 |
Vigabatrin | For Solution; Oral | SUPPL-2 | Pyros Pharms | Labeling | Approved |
| Vigabatrin
ANDA #214961 |
Vigabatrin | For Solution; Oral | SUPPL-2 | Pyros Pharms | Labeling | Approved |
| Vigabatrin
ANDA #214961 |
Vigabatrin | For Solution; Oral | SUPPL-2 | Pyros Pharms | Labeling | Approved |
May 30, 2023
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Fintepla
NDA #212102 |
Fenfluramine Hydrochloride | Solution; Oral | SUPPL-9 | Zogenix Inc | REMS | Approved |
| Obeticholic Acid
ANDA #214862 |
Obeticholic Acid | Tablet; Oral | ORIG-1 | Apotex Inc | Approved | |
| Obeticholic Acid
ANDA #214980 |
Obeticholic Acid | Tablet; Oral | ORIG-1 | Lupin Ltd | Approved | |
| Semglee
BLA #761201 |
Insulin Glargine-Yfgn | Injectable; Injection | SUPPL-7 | Mylan Pharms Inc | Labeling | Approved |
| Vevye
NDA #217469 |
Cyclosporine | Solution; Ophthalmic | ORIG-1 | Novaliq Gmbh | Type 5 - New Formulation or New Manufacturer | Approved |
May 28, 2023
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Albuterol Sulfate
ANDA #207857 |
Albuterol Sulfate | Solution; Inhalation | SUPPL-8 | Sun Pharm | Labeling | Approved |
| Albuterol Sulfate
ANDA #207857 |
Albuterol Sulfate | Solution; Inhalation | SUPPL-8 | Sun Pharm | Labeling | Approved |
| Azithromycin
ANDA #065246 |
Azithromycin | For Suspension; Oral | SUPPL-30 | Pliva | Labeling | Approved |
| Azithromycin
ANDA #065246 |
Azithromycin | For Suspension; Oral | SUPPL-30 | Pliva | Labeling | Approved |
May 26, 2023
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Apixaban
ANDA #210026 |
Apixaban | Tablet; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Dolutegravir, Emtricitabine and Tenofovir Alafenamide
NDA #215448 |
Dolutegravir, Emtricitabine and Tenofovir Alafenamide | Tablet; Oral | ORIG-1 | Aurobindo Pharma Usa | Type 4 - New Combination | Tentative Approval |
| Inpefa
NDA #216203 |
Sotagliflozin | Tablet; Oral | ORIG-1 | Lexicon Pharmaceuticals Inc | Type 1 - New Molecular Entity | Approved |
| Itraconazole
ANDA #076104 |
Itraconazole | Capsule; Oral | SUPPL-24 | Sandoz | Labeling | Approved |
| Itraconazole
ANDA #076104 |
Itraconazole | Capsule; Oral | SUPPL-24 | Sandoz | Labeling | Approved |
| Itraconazole
ANDA #205724 |
Itraconazole | Capsule; Oral | SUPPL-5 | Par Pharm Inc | Labeling | Approved |
| Itraconazole
ANDA #209460 |
Itraconazole | Capsule; Oral | SUPPL-4 | Torrent | Labeling | Approved |
| Itraconazole
ANDA #209460 |
Itraconazole | Capsule; Oral | SUPPL-4 | Torrent | Labeling | Approved |
| Itraconazole
ANDA #212239 |
Itraconazole | Solution; Oral | SUPPL-1 | Annora Pharma | Labeling | Approved |
| Mekinist
NDA #204114 |
Trametinib Dimethyl Sulfoxide | Tablet; Oral | SUPPL-28 | Novartis | Labeling | Approved |
| Metformin Hydrochloride
ANDA #213320 |
Metformin Hydrochloride | Tablet; Oral | SUPPL-2 | Harman Finochem | Manufacturing (CMC) | Approved |
| Opsumit
NDA #204410 |
Macitentan | Tablet; Oral | SUPPL-24 | Actelion | Labeling | Approved |
| Pramipexole Dihydrochloride
ANDA #212797 |
Pramipexole Dihydrochloride | Tablet, Extended Release; Oral | SUPPL-1 | Xiamen Lp Pharm Co | Labeling | Approved |
| Pramipexole Dihydrochloride
ANDA #212797 |
Pramipexole Dihydrochloride | Tablet, Extended Release; Oral | SUPPL-1 | Xiamen Lp Pharm Co | Labeling | Approved |
| Sevelamer Hydrochloride
ANDA #206883 |
Sevelamer Hydrochloride | Tablet; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Tafinlar
NDA #202806 |
Dabrafenib Mesylate | Capsule; Oral | SUPPL-26 | Novartis | Labeling | Approved |
| Tezspire
BLA #761224 |
Tezepelumab-Ekko | Solution; Subcutaneous | SUPPL-3 | Astrazeneca Ab | Labeling | Approved |
| Timolol Maleate
ANDA #217343 |
Timolol Maleate | Solution/Drops; Ophthalmic | ORIG-1 | Micro Labs | Approved | |
| Vasopressin
ANDA #213205 |
Vasopressin | Injectable; Injection | ORIG-1 | Fresenius Kabi Usa | Tentative Approval | |
| Vasopressin
ANDA #213206 |
Vasopressin | Solution; Intravenous | ORIG-1 | Fresenius Kabi Usa | Approved | |
| Zinplava
BLA #761046 |
Bezlotoxumab | Injectable; Injection | SUPPL-12 | Merck Sharp Dohme | Efficacy | Approved |
May 25, 2023
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #203136 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-44 | Amneal Pharms | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #214930 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-9 | Alkem Labs Ltd | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #214930 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-9 | Alkem Labs Ltd | Labeling | Approved |
| Carboprost Tromethamine
ANDA #216939 |
Carboprost Tromethamine | Injectable; Injection | ORIG-1 | Eugia Pharma | Approved | |
| Chlordiazepoxide Hydrochloride and Clidinium Bromide
ANDA #214065 |
Chlordiazepoxide Hydrochloride; Clidinium Bromide | Capsule; Oral | SUPPL-5 | Alkem Labs Ltd | Labeling | Approved |
| Claritin Hives Relief Reditab
NDA #020704 |
Loratadine | Tablet, Orally Disintegrating; Oral | SUPPL-41 | Bayer Healthcare Llc | Labeling | Approved |
| Claritin Reditabs
NDA #020704 |
Loratadine | Tablet, Orally Disintegrating; Oral | SUPPL-41 | Bayer Healthcare Llc | Labeling | Approved |
| Claritin Reditabs
NDA #021993 |
Loratadine | Tablet, Orally Disintegrating; Oral | SUPPL-23 | Bayer Healthcare Llc | Labeling | Approved |
| Eptifibatide
ANDA #206127 |
Eptifibatide | Injectable; Injection | SUPPL-4 | Eugia Pharma | Labeling | Approved |
| Margenza
BLA #761150 |
Margetuximab-Cmkb | Injectable; Injection | SUPPL-5 | Macrogenics Inc | Efficacy | Approved |
| Nitisinone
ANDA #216201 |
Nitisinone | Capsule; Oral | ORIG-1 | Zenara | Approved | |
| Palonosetron Hydrochloride
ANDA #205870 |
Palonosetron Hydrochloride | Injectable; Intravenous | SUPPL-3 | Sagent Pharms Inc | Labeling | Approved |
| Paxlovid
NDA #217188 |
Ritonavir, Nirmatrelvir | Tablet; Oral | ORIG-1 | Pfizer Inc | Type 1 - New Molecular Entity | Approved |
| Posluma
NDA #216023 |
Flotufolastat F-18 | Injectable; Intravenous | ORIG-1 | Blue Earth Diagnostics Ltd. | Type 1 - New Molecular Entity | Approved |
| Sustol
NDA #022445 |
Granisetron | Injection, Extended Release; Subcutaneous | SUPPL-10 | Heron Theraps Inc | Labeling | Approved |
| Sustol
NDA #022445 |
Granisetron | Injection, Extended Release; Subcutaneous | SUPPL-10 | Heron Theraps Inc | Labeling | Approved |
| Topiramate
ANDA #078235 |
Topiramate | Tablet; Oral | SUPPL-32 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate
ANDA #078235 |
Topiramate | Tablet; Oral | SUPPL-33 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate
ANDA #078235 |
Topiramate | Tablet; Oral | SUPPL-32 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate
ANDA #078235 |
Topiramate | Tablet; Oral | SUPPL-33 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate
ANDA #078877 |
Topiramate | Capsule; Oral | SUPPL-22 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate
ANDA #078877 |
Topiramate | Capsule; Oral | SUPPL-24 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate
ANDA #078877 |
Topiramate | Capsule; Oral | SUPPL-22 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate
ANDA #078877 |
Topiramate | Capsule; Oral | SUPPL-24 | Zydus Pharms Usa Inc | Labeling | Approved |
| Triazolam
ANDA #213003 |
Triazolam | Tablet; Oral | SUPPL-1 | Zydus Pharms | Labeling | Approved |
| Triazolam
ANDA #213003 |
Triazolam | Tablet; Oral | SUPPL-1 | Zydus Pharms | Labeling | Approved |
| Ultravist (Pharmacy Bulk)
NDA #021425 |
Iopromide | Injectable; Injection | SUPPL-36 | Bayer Hlthcare | Efficacy | Approved |
| Ultravist 150
NDA #020220 |
Iopromide | Injectable; Injection | SUPPL-54 | Bayer Hlthcare | Efficacy | Approved |
| Ultravist 240
NDA #020220 |
Iopromide | Injectable; Injection | SUPPL-54 | Bayer Hlthcare | Efficacy | Approved |
| Ultravist 300
NDA #020220 |
Iopromide | Injectable; Injection | SUPPL-54 | Bayer Hlthcare | Efficacy | Approved |
| Ultravist 300 In Plastic Container
NDA #020220 |
Iopromide | Injectable; Injection | SUPPL-54 | Bayer Hlthcare | Efficacy | Approved |
| Ultravist 370
NDA #020220 |
Iopromide | Injectable; Injection | SUPPL-54 | Bayer Hlthcare | Efficacy | Approved |
May 24, 2023
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acetazolamide
ANDA #205530 |
Acetazolamide | Tablet; Oral | SUPPL-11 | Heritage Pharma | Labeling | Approved |
| Dextromethorphan Hydrobromide and Quinidine Sulfate
ANDA #202934 |
Dextromethorphan Hydrobromide; Quinidine Sulfate | Capsule; Oral | SUPPL-1 | Actavis Elizabeth | Labeling | Approved |
| Imipramine Hydrochloride
ANDA #083745 |
Imipramine Hydrochloride | Tablet; Oral | SUPPL-123 | Sandoz | Labeling | Approved |
| Imipramine Hydrochloride
ANDA #083745 |
Imipramine Hydrochloride | Tablet; Oral | SUPPL-123 | Sandoz | Labeling | Approved |
| Imipramine Hydrochloride
ANDA #084936 |
Imipramine Hydrochloride | Tablet; Oral | SUPPL-109 | Sandoz | Labeling | Approved |
| Imipramine Hydrochloride
ANDA #084936 |
Imipramine Hydrochloride | Tablet; Oral | SUPPL-109 | Sandoz | Labeling | Approved |
| Imipramine Hydrochloride
ANDA #084937 |
Imipramine Hydrochloride | Tablet; Oral | SUPPL-129 | Sandoz | Labeling | Approved |
| Imipramine Hydrochloride
ANDA #084937 |
Imipramine Hydrochloride | Tablet; Oral | SUPPL-129 | Sandoz | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #216266 |
Lisdexamfetamine Dimesylate | Capsule; Oral | ORIG-1 | Prinston Pharma Inc | Tentative Approval | |
| Lumizyme
BLA #125291 |
Alglucosidase Alfa | Powder; Iv (Infusion) | SUPPL-159 | Genzyme | Labeling | Approved |
| Methimazole
ANDA #209827 |
Methimazole | Tablet; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Metronidazole In Plastic Container
ANDA #217665 |
Metronidazole In Plastic Container | Injectable; Injection | ORIG-1 | Amneal | Approved | |
| Nasonex 24hr Allergy
NDA #215712 |
Mometasone Furoate | Spray, Metered; Nasal | SUPPL-15 | Perrigo Pharma Intl | Labeling | Approved |
| Norethindrone
ANDA #091209 |
Norethindrone | Tablet; Oral-28 | SUPPL-10 | Glenmark Generics | Labeling | Approved |
| Norethindrone
ANDA #091209 |
Norethindrone | Tablet; Oral-28 | SUPPL-10 | Glenmark Generics | Labeling | Approved |
| Ondansetron Hydrochloride
ANDA #206846 |
Ondansetron Hydrochloride | Injectable; Injection | SUPPL-8 | Accord Hlthcare | Labeling | Approved |
| Ondansetron Hydrochloride Preservative Free
ANDA #206845 |
Ondansetron Hydrochloride | Injectable; Injection | SUPPL-8 | Accord Hlthcare | Labeling | Approved |
| Oxybutynin Chloride
ANDA #206121 |
Oxybutynin Chloride | Tablet, Extended Release; Oral | SUPPL-6 | Unique | Labeling | Approved |
| Pazopanib
ANDA #215837 |
Pazopanib | Tablet; Oral | ORIG-1 | Sun Pharm Inds Ltd | Tentative Approval | |
| Readyprep Chg
NDA #207964 |
Chlorhexidine Gluconate | Cloth; Topical | SUPPL-3 | Medline Industries | Manufacturing (CMC) | Approved |
| Risedronate Sodium
ANDA #079215 |
Risedronate Sodium | Tablet; Oral | SUPPL-4 | Teva Pharms Usa | Labeling | Approved |
| Risedronate Sodium
ANDA #079215 |
Risedronate Sodium | Tablet; Oral | SUPPL-4 | Teva Pharms Usa | Labeling | Approved |
| Rocuronium Bromide
ANDA #217034 |
Rocuronium Bromide | Injectable; Injection | ORIG-1 | Hikma | Approved | |
| Tofacitinib
ANDA #216940 |
Tofacitinib | Tablet; Oral | ORIG-1 | Heilongjiang Zbd Pharmaceutical Co Ltd | Tentative Approval | |
| Venlafaxine Hydrochloride
ANDA #214419 |
Venlafaxine Hydrochloride | Tablet, Extended Release; Oral | SUPPL-1 | Ascent Pharms Inc | Labeling | Approved |
| Venlafaxine Hydrochloride
ANDA #214419 |
Venlafaxine Hydrochloride | Tablet, Extended Release; Oral | SUPPL-1 | Ascent Pharms Inc | Labeling | Approved |
May 23, 2023
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Baclofen
ANDA #090334 |
Baclofen | Tablet; Oral | SUPPL-3 | Appco | Labeling | Approved |
| Brixadi
NDA #210136 |
Buprenorphine | Injection, Extended Release; Subcutaneous | ORIG-1 | Braeburn Pharma Inc | Type 3 - New Dosage Form | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Film; Buccal, Sublingual | SUPPL-23 | Alvogen | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Film; Buccal, Sublingual | SUPPL-15 | Alvogen | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Film; Buccal, Sublingual | SUPPL-21 | Alvogen | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Film; Buccal, Sublingual | SUPPL-15 | Alvogen | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Film; Buccal, Sublingual | SUPPL-21 | Alvogen | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205954 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Film; Buccal, Sublingual | SUPPL-23 | Alvogen | Labeling | Approved |
| Chorionic Gonadotropin
BLA #017016 |
Gonadotropin, Chorionic | Injectable; Injection | SUPPL-172 | Ferring | Labeling | Approved |
| Divigel
NDA #022038 |
Estradiol | Gel; Transdermal | SUPPL-10 | Vertical Pharms | Labeling | Approved |
| Exemestane
ANDA #200898 |
Exemestane | Tablet; Oral | SUPPL-12 | Alvogen | Labeling | Approved |
| Fexofenadine Hydrochloride
ANDA #213466 |
Fexofenadine Hydrochloride | Suspension; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-4 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-5 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-8 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-9 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-10 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-11 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-4 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-6 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-8 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-9 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-10 | Mylan Pharms Inc | Labeling | Approved |
| Gabapentin
ANDA #090335 |
Gabapentin | Tablet; Oral | SUPPL-11 | Mylan Pharms Inc | Labeling | Approved |
| Haloperidol Decanoate
ANDA #216730 |
Haloperidol Decanoate | Injectable; Injection | ORIG-1 | Mankind Pharma | Approved | |
| Levetiracetam In Sodium Chloride
ANDA #206880 |
Levetiracetam | Injectable; Intravenous | SUPPL-7 | Gland Pharma Ltd | Labeling | Approved |
| Levetiracetam In Sodium Chloride
ANDA #207160 |
Levetiracetam | Injectable; Intravenous | SUPPL-5 | Eugia Pharma | Labeling | Approved |
| Methylphenidate Hydrochloride
ANDA #214447 |
Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
ANDA #203580 |
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil | Tablet; Oral | SUPPL-18 | Torrent | Labeling | Approved |
| Posaconazole
ANDA #214842 |
Posaconazole | Injectable; Injection | ORIG-1 | Eugia Pharma Speclts | Tentative Approval | |
| Regadenoson
ANDA #217455 |
Regadenoson | Solution; Intravenous | ORIG-1 | Baxter Hlthcare Corp | Approved | |
| Ropivacaine Hydrochloride
ANDA #090194 |
Ropivacaine Hydrochloride | Solution; Injection | SUPPL-2 | Hospira | Labeling | Approved |
| Ropivacaine Hydrochloride
ANDA #090194 |
Ropivacaine Hydrochloride | Solution; Injection | SUPPL-5 | Hospira | Labeling | Approved |
| Simvastatin
ANDA #090383 |
Simvastatin | Tablet; Oral | SUPPL-13 | Micro Labs | Labeling | Approved |
| Simvastatin
ANDA #090383 |
Simvastatin | Tablet; Oral | SUPPL-12 | Micro Labs | Labeling | Approved |
| Simvastatin
ANDA #090383 |
Simvastatin | Tablet; Oral | SUPPL-13 | Micro Labs | Labeling | Approved |
| Simvastatin
ANDA #090383 |
Simvastatin | Tablet; Oral | SUPPL-14 | Micro Labs | Labeling | Approved |
| Simvastatin
ANDA #090383 |
Simvastatin | Tablet; Oral | SUPPL-15 | Micro Labs | Labeling | Approved |
| Simvastatin
ANDA #090383 |
Simvastatin | Tablet; Oral | SUPPL-15 | Micro Labs | Labeling | Approved |
| Tofacitinib
ANDA #216770 |
Tofacitinib | Tablet; Oral | ORIG-1 | Teva Pharms Inc | Tentative Approval | |
| Xacduro
NDA #216974 |
Sulbactam;Durlobactam | Injectable; Injection | ORIG-1 | Entasis Therapeutics Inc | Type 1 - New Molecular Entity and Type 4 - New Combination | Approved |
| Yuflyma
BLA #761219 |
Adalimumab-Aaty | Injectable; Injection | ORIG-1 | Celltrion | Type 2 - New Active Ingredient | Approved |
| Zolmitriptan
ANDA #202279 |
Zolmitriptan | Tablet; Oral | SUPPL-5 | Jubilant Generics | Labeling | Approved |
May 22, 2023
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Ayvakit
NDA #212608 |
Avapritinib | Tablet; Oral | SUPPL-13 | Blueprint Medicines | Efficacy | Approved |
| Clobazam
ANDA #209718 |
Clobazam | Tablet; Oral | SUPPL-4 | Amneal Pharms Co | Labeling | Approved |
| Clobazam
ANDA #209718 |
Clobazam | Tablet; Oral | SUPPL-4 | Amneal Pharms Co | Labeling | Approved |
| Clobazam
ANDA #209718 |
Clobazam | Tablet; Oral | SUPPL-9 | Amneal Pharms Co | Labeling | Approved |
| Clobazam
ANDA #209718 |
Clobazam | Tablet; Oral | SUPPL-4 | Amneal Pharms Co | Labeling | Approved |
| Clobazam
ANDA #209718 |
Clobazam | Tablet; Oral | SUPPL-9 | Amneal Pharms Co | Labeling | Approved |
| Clobazam
ANDA #210746 |
Clobazam | Suspension; Oral | SUPPL-7 | Vistapharm | Labeling | Approved |
| Clobazam
ANDA #210746 |
Clobazam | Suspension; Oral | SUPPL-7 | Vistapharm | Labeling | Approved |
| Clobazam
ANDA #210978 |
Clobazam | Suspension; Oral | SUPPL-6 | Taro | Labeling | Approved |
| Clobazam
ANDA #210978 |
Clobazam | Suspension; Oral | SUPPL-6 | Taro | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209647 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-5 | Amneal Pharms Ny | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209647 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-4 | Amneal Pharms Ny | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209647 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-5 | Amneal Pharms Ny | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209647 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-7 | Amneal Pharms Ny | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209647 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-4 | Amneal Pharms Ny | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209647 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-5 | Amneal Pharms Ny | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209647 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-7 | Amneal Pharms Ny | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209735 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-9 | Sun Pharm | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209735 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-11 | Sun Pharm | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209735 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-13 | Sun Pharm | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209735 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-9 | Sun Pharm | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209735 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-11 | Sun Pharm | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #209735 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-13 | Sun Pharm | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #210559 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-6 | Indchemie Health | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #210559 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-3 | Indchemie Health | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #210559 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-6 | Indchemie Health | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #210559 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-3 | Indchemie Health | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #210559 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | SUPPL-6 | Indchemie Health | Labeling | Approved |
| Hydromorphone Hydrochloride
ANDA #204278 |
Hydromorphone Hydrochloride | Tablet, Extended Release; Oral | SUPPL-17 | Padagis Us | Labeling | Approved |
| Hydromorphone Hydrochloride
ANDA #204278 |
Hydromorphone Hydrochloride | Tablet, Extended Release; Oral | SUPPL-17 | Padagis Us | Labeling | Approved |
| Hydromorphone Hydrochloride
ANDA #204278 |
Hydromorphone Hydrochloride | Tablet, Extended Release; Oral | SUPPL-17 | Padagis Us | Labeling | Approved |
| Itraconazole
ANDA #206741 |
Itraconazole | Capsule; Oral | SUPPL-14 | Alembic | Labeling | Approved |
| Itraconazole
ANDA #206741 |
Itraconazole | Capsule; Oral | SUPPL-14 | Alembic | Labeling | Approved |
| Itraconazole
ANDA #206741 |
Itraconazole | Capsule; Oral | SUPPL-14 | Alembic | Labeling | Approved |
| Levetiracetam
ANDA #201157 |
Levetiracetam | Solution; Oral | SUPPL-8 | Pharm Assoc | Labeling | Approved |
| Levetiracetam
ANDA #204312 |
Levetiracetam | Injectable; Intravenous | SUPPL-9 | Eugia Pharma | Labeling | Approved |
| Levetiracetam
ANDA #211954 |
Levetiracetam | Injectable; Intravenous | SUPPL-2 | Micro Labs | Labeling | Approved |
| Levetiracetam
ANDA #211954 |
Levetiracetam | Injectable; Intravenous | SUPPL-1 | Micro Labs | Labeling | Approved |
| Levetiracetam
ANDA #211954 |
Levetiracetam | Injectable; Intravenous | SUPPL-2 | Micro Labs | Labeling | Approved |
| Levoleucovorin Calcium
ANDA #217314 |
Levoleucovorin Calcium | Solution; Intravenous | ORIG-1 | Hainan Poly Pharm | Approved | |
| Opvee
NDA #217470 |
Nalmefene | Spray; Nasal | ORIG-1 | Opiant Pharmaceuticals Inc | Type 3 - New Dosage Form | Approved |
| Pemetrexed
NDA #215179 |
Pemetrexed | Solution; Intravenous | ORIG-1 | Shilpa Medicare Ltd | Type 5 - New Formulation or New Manufacturer | Approved |
| Rydapt
NDA #207997 |
Midostaurin | Capsule; Oral | SUPPL-10 | Novartis | Labeling | Approved |
| Vigabatrin
ANDA #214961 |
Vigabatrin | For Solution; Oral | SUPPL-2 | Pyros Pharms | Labeling | Approved |
| Vigabatrin
ANDA #214961 |
Vigabatrin | For Solution; Oral | SUPPL-2 | Pyros Pharms | Labeling | Approved |
| Vigabatrin
ANDA #214961 |
Vigabatrin | For Solution; Oral | SUPPL-2 | Pyros Pharms | Labeling | Approved |
May 19, 2023
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acetazolamide
ANDA #207401 |
Acetazolamide | Capsule, Extended Release; Oral | SUPPL-1 | Micro Labs Ltd India | Labeling | Approved |
| Acetazolamide
ANDA #207659 |
Acetazolamide | Capsule, Extended Release; Oral | SUPPL-3 | Accord Hlthcare | Labeling | Approved |
| Aliskiren Hemifumarate
ANDA #206665 |
Aliskiren Hemifumarate | Tablet; Oral | SUPPL-2 | Anchen Pharms | Labeling | Approved |
| Amitriptyline Hydrochloride
ANDA #217411 |
Amitriptyline Hydrochloride | Tablet; Oral | ORIG-1 | Graviti Pharms | Approved | |
| Beyaz
NDA #022532 |
Drospirenone; Ethinyl Estradiol; Levomefolate Calcium | Tablet; Oral | SUPPL-10 | Bayer Hlthcare | Labeling | Approved |
| Carboprost Tromethamine
ANDA #216824 |
Carboprost Tromethamine | Injectable; Injection | ORIG-1 | Welding | Approved | |
| Clozaril
NDA #019758 |
Clozapine | Tablet; Oral | SUPPL-103 | Heritage Life | Labeling | Approved |
| Colchicine
ANDA #210425 |
Colchicine | Tablet; Oral | SUPPL-2 | Granules | Labeling | Approved |
| Colchicine
ANDA #210425 |
Colchicine | Tablet; Oral | SUPPL-2 | Granules | Labeling | Approved |
| Colchicine
ANDA #210425 |
Colchicine | Tablet; Oral | SUPPL-2 | Granules | Labeling | Approved |
| Deferasirox
ANDA #209433 |
Deferasirox | Tablet, For Suspension; Oral | SUPPL-1 | Ichnos | Labeling | Approved |
| Deferasirox
ANDA #209433 |
Deferasirox | Tablet, For Suspension; Oral | SUPPL-2 | Ichnos | Labeling | Approved |
| Diclofenac Sodium and Misoprostol
ANDA #200158 |
Diclofenac Sodium; Misoprostol | Tablet, Delayed Release; Oral | SUPPL-7 | Sandoz | Labeling | Approved |
| Diclofenac Sodium and Misoprostol
ANDA #200158 |
Diclofenac Sodium; Misoprostol | Tablet, Delayed Release; Oral | SUPPL-8 | Sandoz | Labeling | Approved |
| Diclofenac Sodium and Misoprostol
ANDA #200158 |
Diclofenac Sodium; Misoprostol | Tablet, Delayed Release; Oral | SUPPL-9 | Sandoz | Labeling | Approved |
| Diclofenac Sodium and Misoprostol
ANDA #200158 |
Diclofenac Sodium; Misoprostol | Tablet, Delayed Release; Oral | SUPPL-10 | Sandoz | Labeling | Approved |
| Diclofenac Sodium and Misoprostol
ANDA #200158 |
Diclofenac Sodium; Misoprostol | Tablet, Delayed Release; Oral | SUPPL-11 | Sandoz | Labeling | Approved |
| Diclofenac Sodium and Misoprostol
ANDA #200158 |
Diclofenac Sodium; Misoprostol | Tablet, Delayed Release; Oral | SUPPL-12 | Sandoz | Labeling | Approved |
| Diclofenac Sodium and Misoprostol
ANDA #200158 |
Diclofenac Sodium; Misoprostol | Tablet, Delayed Release; Oral | SUPPL-13 | Sandoz | Labeling | Approved |
| Diclofenac Sodium and Misoprostol
ANDA #200158 |
Diclofenac Sodium; Misoprostol | Tablet, Delayed Release; Oral | SUPPL-14 | Sandoz | Labeling | Approved |
| Drospirenone and Ethinyl Estradiol
ANDA #205876 |
Drospirenone; Ethinyl Estradiol | Tablet; Oral-28 | SUPPL-3 | Apotex | Labeling | Approved |
| Drospirenone and Ethinyl Estradiol
ANDA #205876 |
Drospirenone; Ethinyl Estradiol | Tablet; Oral-28 | SUPPL-6 | Apotex | Labeling | Approved |
| Drospirenone and Ethinyl Estradiol
ANDA #205876 |
Drospirenone; Ethinyl Estradiol | Tablet; Oral-28 | SUPPL-3 | Apotex | Labeling | Approved |
| Drospirenone and Ethinyl Estradiol
ANDA #205876 |
Drospirenone; Ethinyl Estradiol | Tablet; Oral-28 | SUPPL-6 | Apotex | Labeling | Approved |
| Epkinly
BLA #761324 |
Epcoritamab-Bysp | Injectable; Subcutaneous | ORIG-1 | Genmab Us, Inc. | Type 1 - New Molecular Entity | Approved |
| Lamotrigine
ANDA #200672 |
Lamotrigine | Tablet, Extended Release; Oral | SUPPL-13 | Actavis Elizabeth | Labeling | Approved |
| Lamotrigine
ANDA #200672 |
Lamotrigine | Tablet, Extended Release; Oral | SUPPL-12 | Actavis Elizabeth | Labeling | Approved |
| Lamotrigine
ANDA #200672 |
Lamotrigine | Tablet, Extended Release; Oral | SUPPL-13 | Actavis Elizabeth | Labeling | Approved |
| Lamotrigine
ANDA #200672 |
Lamotrigine | Tablet, Extended Release; Oral | SUPPL-12 | Actavis Elizabeth | Labeling | Approved |
| Lamotrigine
ANDA #200672 |
Lamotrigine | Tablet, Extended Release; Oral | SUPPL-13 | Actavis Elizabeth | Labeling | Approved |
| Levetiracetam
ANDA #090263 |
Levetiracetam | Solution; Oral | SUPPL-15 | Chartwell Molecular | Labeling | Approved |
| Levetiracetam
ANDA #090263 |
Levetiracetam | Solution; Oral | SUPPL-12 | Chartwell Molecular | Labeling | Approved |
| Levetiracetam
ANDA #090263 |
Levetiracetam | Solution; Oral | SUPPL-13 | Chartwell Molecular | Labeling | Approved |
| Levetiracetam
ANDA #090263 |
Levetiracetam | Solution; Oral | SUPPL-14 | Chartwell Molecular | Labeling | Approved |
| Levetiracetam
ANDA #090263 |
Levetiracetam | Solution; Oral | SUPPL-15 | Chartwell Molecular | Labeling | Approved |
| Levetiracetam
ANDA #090263 |
Levetiracetam | Solution; Oral | SUPPL-11 | Chartwell Molecular | Labeling | Approved |
| Levetiracetam
ANDA #090263 |
Levetiracetam | Solution; Oral | SUPPL-12 | Chartwell Molecular | Labeling | Approved |
| Levetiracetam
ANDA #090263 |
Levetiracetam | Solution; Oral | SUPPL-13 | Chartwell Molecular | Labeling | Approved |
| Levetiracetam
ANDA #090263 |
Levetiracetam | Solution; Oral | SUPPL-14 | Chartwell Molecular | Labeling | Approved |
| Levetiracetam
ANDA #090263 |
Levetiracetam | Solution; Oral | SUPPL-15 | Chartwell Molecular | Labeling | Approved |
| Levetiracetam
ANDA #090992 |
Levetiracetam | Solution; Oral | SUPPL-7 | Amneal Pharms | Labeling | Approved |
| Levetiracetam
ANDA #090992 |
Levetiracetam | Solution; Oral | SUPPL-6 | Amneal Pharms | Labeling | Approved |
| Levetiracetam
ANDA #090992 |
Levetiracetam | Solution; Oral | SUPPL-7 | Amneal Pharms | Labeling | Approved |
| Levetiracetam
ANDA #090992 |
Levetiracetam | Solution; Oral | SUPPL-8 | Amneal Pharms | Labeling | Approved |
| Levetiracetam
ANDA #090992 |
Levetiracetam | Solution; Oral | SUPPL-9 | Amneal Pharms | Labeling | Approved |
| Levetiracetam
ANDA #090992 |
Levetiracetam | Solution; Oral | SUPPL-5 | Amneal Pharms | Labeling | Approved |
| Levetiracetam
ANDA #090992 |
Levetiracetam | Solution; Oral | SUPPL-6 | Amneal Pharms | Labeling | Approved |
| Levetiracetam
ANDA #090992 |
Levetiracetam | Solution; Oral | SUPPL-7 | Amneal Pharms | Labeling | Approved |
| Levetiracetam
ANDA #090992 |
Levetiracetam | Solution; Oral | SUPPL-8 | Amneal Pharms | Labeling | Approved |
| Levetiracetam
ANDA #090992 |
Levetiracetam | Solution; Oral | SUPPL-9 | Amneal Pharms | Labeling | Approved |
| Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container
ANDA #205833 |
Moxifloxacin Hydrochloride | Solution; Intravenous | SUPPL-9 | Mylan Labs Ltd | Labeling | Approved |
| Safyral
NDA #022574 |
Drospirenone; Ethinyl Estradiol; Levomefolate Calcium | Tablet; Oral | SUPPL-10 | Bayer Hlthcare | Labeling | Approved |
| Sevelamer Carbonate
ANDA #206094 |
Sevelamer Carbonate | Tablet; Oral | SUPPL-3 | Dr Reddys | Labeling | Approved |
| Sevelamer Carbonate
ANDA #206094 |
Sevelamer Carbonate | Tablet; Oral | SUPPL-5 | Dr Reddys | Labeling | Approved |
| Tetrabenazine
ANDA #206093 |
Tetrabenazine | Tablet; Oral | SUPPL-1 | Apotex | Labeling | Approved |
| Tetrabenazine
ANDA #206093 |
Tetrabenazine | Tablet; Oral | SUPPL-1 | Apotex | Labeling | Approved |
| Tetrabenazine
ANDA #206093 |
Tetrabenazine | Tablet; Oral | SUPPL-1 | Apotex | Labeling | Approved |
| Yasmin
NDA #021098 |
Drospirenone; Ethinyl Estradiol | Tablet; Oral-28 | SUPPL-29 | Bayer Hlthcare | Labeling | Approved |
| Yaz
NDA #021676 |
Drospirenone; Ethinyl Estradiol | Tablet; Oral | SUPPL-20 | Bayer Hlthcare | Labeling | Approved |
| Zoledronic Acid
ANDA #202923 |
Zoledronic Acid | Injectable; Intravenous | SUPPL-14 | Usv | Labeling | Approved |
| Zoledronic Acid
ANDA #202923 |
Zoledronic Acid | Injectable; Intravenous | SUPPL-7 | Usv | Labeling | Approved |
| Zoledronic Acid
ANDA #202923 |
Zoledronic Acid | Injectable; Intravenous | SUPPL-14 | Usv | Labeling | Approved |
May 18, 2023
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Clarithromycin
ANDA #065136 |
Clarithromycin | Tablet; Oral | SUPPL-27 | Sandoz | Labeling | Approved |
| Clarithromycin
ANDA #065136 |
Clarithromycin | Tablet; Oral | SUPPL-20 | Sandoz | Labeling | Approved |
| Clarithromycin
ANDA #065136 |
Clarithromycin | Tablet; Oral | SUPPL-22 | Sandoz | Labeling | Approved |
| Clarithromycin
ANDA #065136 |
Clarithromycin | Tablet; Oral | SUPPL-25 | Sandoz | Labeling | Approved |
| Clarithromycin
ANDA #065136 |
Clarithromycin | Tablet; Oral | SUPPL-27 | Sandoz | Labeling | Approved |
| Clarithromycin
ANDA #065136 |
Clarithromycin | Tablet; Oral | SUPPL-29 | Sandoz | Labeling | Approved |
| Clarithromycin
ANDA #065136 |
Clarithromycin | Tablet; Oral | SUPPL-25 | Sandoz | Labeling | Approved |
| Clarithromycin
ANDA #065144 |
Clarithromycin | Tablet; Oral | SUPPL-19 | Sandoz | Labeling | Approved |
| Clarithromycin
ANDA #065144 |
Clarithromycin | Tablet; Oral | SUPPL-21 | Sandoz | Labeling | Approved |
| Clarithromycin
ANDA #065144 |
Clarithromycin | Tablet; Oral | SUPPL-24 | Sandoz | Labeling | Approved |
| Clarithromycin
ANDA #065144 |
Clarithromycin | Tablet; Oral | SUPPL-26 | Sandoz | Labeling | Approved |
| Clarithromycin
ANDA #065144 |
Clarithromycin | Tablet; Oral | SUPPL-28 | Sandoz | Labeling | Approved |
| Clarithromycin
ANDA #065144 |
Clarithromycin | Tablet; Oral | SUPPL-24 | Sandoz | Labeling | Approved |
| Cyltezo
BLA #761058 |
Adalimumab-Adbm | Injectable; Injection | SUPPL-16 | Boehringer Ingelheim | Efficacy | Approved |
| Femhrt
NDA #021065 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet; Oral | SUPPL-25 | Apil | Labeling | Approved |
| Femhrt
NDA #021065 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet; Oral | SUPPL-26 | Apil | Labeling | Approved |
| Imbruvica
NDA #205552 |
Ibrutinib | Capsule; Oral | SUPPL-40 | Pharmacyclics Inc | Efficacy | Approved |
| Imbruvica
NDA #210563 |
Ibrutinib | Tablet; Oral | SUPPL-17 | Pharmacyclics Inc | Efficacy | Approved |
| Miebo
NDA #216675 |
Perfluorohexyloctane | Solution/Drops; Ophthalmic | ORIG-1 | Bausch and Lomb Inc | Type 1 - New Molecular Entity | Approved |
| Naloxone Hydrochloride
ANDA #070639 |
Naloxone Hydrochloride | Injectable; Injection | SUPPL-19 | Intl Medication | Labeling | Approved |
| Naloxone Hydrochloride
ANDA #070639 |
Naloxone Hydrochloride | Injectable; Injection | SUPPL-19 | Intl Medication | Labeling | Approved |
| Phyrago
NDA #216099 |
Dasatinib | Tablet; Oral | ORIG-1 | Nanocopoeia Llc | Tentative Approval | |
| Rinvoq
NDA #211675 |
Upadacitinib | Tablet, Extended Release; Oral | SUPPL-15 | Abbvie | Efficacy | Approved |
| Venlafaxine Hydrochloride
ANDA #217390 |
Venlafaxine Hydrochloride | Capsule, Extended Release; Oral | ORIG-1 | Granules | Approved |
May 17, 2023
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Briviact
NDA #205836 |
Brivaracetam | Tablet; Oral | SUPPL-14 | Ucb Inc | Labeling | Approved |
| Briviact
NDA #205837 |
Brivaracetam | Solution; Intravenous | SUPPL-11 | Ucb Inc | Labeling | Approved |
| Briviact
NDA #205837 |
Brivaracetam | Solution; Intravenous | SUPPL-11 | Ucb Inc | Labeling | Approved |
| Briviact
NDA #205838 |
Brivaracetam | Solution; Oral | SUPPL-11 | Ucb Inc | Labeling | Approved |
| Briviact
NDA #205838 |
Brivaracetam | Solution; Oral | SUPPL-11 | Ucb Inc | Labeling | Approved |
| Clinolipid 20%
NDA #204508 |
Olive Oil; Soybean Oil | Emulsion; Intravenous | SUPPL-19 | Baxter Hlthcare Corp | Labeling | Approved |
| Clinolipid 20%
NDA #204508 |
Olive Oil; Soybean Oil | Emulsion; Intravenous | SUPPL-19 | Baxter Hlthcare Corp | Labeling | Approved |
| Clinolipid 20%
NDA #204508 |
Olive Oil; Soybean Oil | Emulsion; Intravenous | SUPPL-21 | Baxter Hlthcare Corp | Labeling | Approved |
| Intralipid 10%
NDA #017643 |
Soybean Oil | Injectable; Injection | SUPPL-83 | Fresenius | Labeling | Approved |
| Intralipid 20%
NDA #018449 |
Soybean Oil | Injectable; Injection | SUPPL-50 | Fresenius | Labeling | Approved |
| Intralipid 20%
NDA #018449 |
Soybean Oil | Injectable; Injection | SUPPL-51 | Fresenius | Labeling | Approved |
| Intralipid 20%
NDA #020248 |
Soybean Oil | Injectable; Injection | SUPPL-27 | Fresenius | Labeling | Approved |
| Intralipid 20%
NDA #020248 |
Soybean Oil | Injectable; Injection | SUPPL-28 | Fresenius | Labeling | Approved |
| Intralipid 30%
NDA #019942 |
Soybean Oil | Injectable; Injection | SUPPL-21 | Fresenius | Labeling | Approved |
| Isosulfan Blue
ANDA #210294 |
Isosulfan Blue | Injectable; Injection | ORIG-1 | Am Regent | Approved | |
| Kabiven In Plastic Container
NDA #200656 |
Amino Acids; Calcium Chloride; Dextrose; Magnesium Sulfate; Potassium Chloride; Sodium Acetate; Sodium Glycerophosphate; Soybean Oil | Emulsion; Intravenous | SUPPL-18 | Fresenius Kabi Usa | Labeling | Approved |
| Levetiracetam
ANDA #090876 |
Levetiracetam | Injectable; Intravenous | SUPPL-3 | Fresenius Kabi Usa | Labeling | Approved |
| Levetiracetam
ANDA #090876 |
Levetiracetam | Injectable; Intravenous | SUPPL-4 | Fresenius Kabi Usa | Labeling | Approved |
| Nutrilipid 10%
NDA #019531 |
Soybean Oil | Injectable; Injection | SUPPL-16 | B Braun | Labeling | Approved |
| Nutrilipid 10%
NDA #019531 |
Soybean Oil | Injectable; Injection | SUPPL-13 | B Braun | Manufacturing (CMC) | Approved |
| Nutrilipid 20%
NDA #019531 |
Soybean Oil | Injectable; Injection | SUPPL-16 | B Braun | Labeling | Approved |
| Nutrilipid 20%
NDA #019531 |
Soybean Oil | Injectable; Injection | SUPPL-13 | B Braun | Manufacturing (CMC) | Approved |
| Omegaven
NDA #210589 |
Fish Oil Triglycerides | Emulsion; Intravenous | SUPPL-3 | Fresenius Kabi Usa | Labeling | Approved |
| Perikabiven In Plastic Container
NDA #200656 |
Amino Acids; Calcium Chloride; Dextrose; Magnesium Sulfate; Potassium Chloride; Sodium Acetate; Sodium Glycerophosphate; Soybean Oil | Emulsion; Intravenous | SUPPL-18 | Fresenius Kabi Usa | Labeling | Approved |
| Smoflipid 20%
NDA #207648 |
Fish Oil; Medium Chain Triglycerides; Olive Oil; Soybean Oil | Emulsion; Intravenous | SUPPL-10 | Fresenius Kabi Usa | Labeling | Approved |
| Spironolactone and Hydrochlorothiazide
ANDA #089534 |
Hydrochlorothiazide; Spironolactone | Tablet; Oral | SUPPL-49 | Sun Pharm Industries | Labeling | Approved |
| Spironolactone and Hydrochlorothiazide
ANDA #089534 |
Hydrochlorothiazide; Spironolactone | Tablet; Oral | SUPPL-50 | Sun Pharm Industries | Labeling | Approved |
| Spironolactone and Hydrochlorothiazide
ANDA #089534 |
Hydrochlorothiazide; Spironolactone | Tablet; Oral | SUPPL-55 | Sun Pharm Industries | Labeling | Approved |