Drugs@FDA: FDA Approved Drug Products
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.
June 23, 2017
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bevyxxa NDA #208383 |
Betrixaban | Capsule; Oral | ORIG-1 | Portola Pharma Inc | Type 1 - New Molecular Entity | Approved |
June 22, 2017
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Amantadine Hydrochloride ANDA #208107 |
Amantadine Hydrochloride | Capsule; Oral | SUPPL-2 | Watson Labs Inc | Manufacturing (CMC) | Approved |
| Hydrocodone Bitartrate and Acetaminophen ANDA #207172 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | ORIG-1 | Lannett Holdings Inc | Approved | |
| Mekinist NDA #204114 |
Trametinib Dimethyl Sulfoxide | Tablet; Oral | SUPPL-5 | Novartis Pharms Corp | Efficacy | Approved |
| Primaquine NDA #008316 |
Primaquine Phosphate | Tablet; Oral | SUPPL-23 | Sanofi Aventis Us | Labeling | Approved |
| Rituxan Hycela BLA #761064 |
Hyaluronidase;Rituximab | Injectable; Injection | ORIG-1 | Genentech Inc | Type 5 - New Formulation or New Manufacturer | Approved |
| Rituxan Hycela BLA #761064 |
Hyaluronidase;Rituximab | Injectable; Injection | SUPPL-1 | Genentech Inc | Type 5 - New Formulation or New Manufacturer | Approved |
| Simponi BLA #125289 |
Golimumab | Injectable; Injection | SUPPL-133 | Centocor Ortho Biotech Inc | Efficacy | Approved |
| Tafinlar NDA #202806 |
Dabrafenib Mesylate | Capsule; Oral | SUPPL-6 | Novartis Pharms Corp | Efficacy | Approved |
June 21, 2017
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Amantadine Hydrochloride ANDA #208966 |
Amantadine Hydrochloride | Capsule; Oral | ORIG-1 | Alembic Pharms Ltd | Approved | |
| Children's Advil NDA #020589 |
Ibuprofen | Suspension; Oral | SUPPL-35 | Pfizer | Labeling | Approved |
| Children's Advil-Flavored NDA #020589 |
Ibuprofen | Suspension; Oral | SUPPL-35 | Pfizer | Labeling | Approved |
| Daraprim NDA #008578 |
Pyrimethamine | Tablet; Oral | SUPPL-20 | Turing Pharms Llc | Labeling | Approved |
| Estrace ANDA #086069 |
Estradiol | Cream; Vaginal | SUPPL-23 | Allergan Sales Llc | Labeling | Approved |
| Granix BLA #125294 |
Tbo-Filgrastim | Injectable; Injection | SUPPL-42 | Sicor Biotech | Labeling | Approved |
| Hydrocodone Bitartrate and Acetaminophen ANDA #209036 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | ORIG-1 | Abhai Llc | Approved | |
| Hydrocodone Bitartrate and Acetaminophen ANDA #209037 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | ORIG-1 | Abhai Llc | Approved | |
| Imatinib Mesylate ANDA #204644 |
Imatinib Mesylate | Tablet; Oral | ORIG-1 | Mylan Pharms Inc | Approved | |
| Synribo NDA #203585 |
Omacetaxine Mepesuccinate | Powder; Subcutaneous | SUPPL-5 | Teva Pharms Intl | Labeling | Approved |
June 20, 2017
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acetazolamide Sodium ANDA #205358 |
Acetazolamide Sodium | Injectable; Injection | ORIG-1 | Par Sterile Products | Approved | |
| Candesartan Cilexetil ANDA #209119 |
Candesartan Cilexetil | Tablet; Oral | ORIG-1 | Alembic Pharms Ltd | Approved | |
| Hydrocodone Bitartrate and Acetaminophen ANDA #207171 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | ORIG-1 | Lannett Holdings Inc | Approved | |
| Lidocaine ANDA #206297 |
Lidocaine | Ointment; Topical | SUPPL-3 | Amneal Pharms | Manufacturing (CMC) | Approved |
| Metronidazole ANDA #208681 |
Metronidazole | Tablet; Oral | ORIG-1 | Orit Labs Llc | Approved | |
| Mydayis NDA #022063 |
Mixed Salts Of A Single-Entity Amphetamine | Capsule, Extended Release; Oral | ORIG-1 | Shire Dev Llc | Type 3 - New Dosage Form | Approved |
| Paroxetine Mesylate ANDA #207139 |
Paroxetine Mesylate | Capsule; Oral | ORIG-1 | Actavis Labs Fl Inc | Approved | |
| Piroxicam ANDA #206136 |
Piroxicam | Capsule; Oral | ORIG-1 | Pii | Approved | |
| Solifenacin Succinate ANDA #209239 |
Solifenacin Succinate | Tablet; Oral | ORIG-1 | Glenmark Pharms | Tentative Approval |
June 19, 2017
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Azithromycin ANDA #207566 |
Azithromycin | Tablet; Oral | ORIG-1 | Cspc Ouyi Pharmaceutical Co. Ltd. | Tentative Approval | |
| Baxdela NDA #208610 |
Delafloxacin | Tablet; Oral | ORIG-1 | Melinta Therapeutics Inc | Type 1 - New Molecular Entity | Approved |
| Baxdela NDA #208611 |
Delafloxacin | Injectable; Injection | ORIG-1 | Melinta Therapeutics Inc | Type 1 - New Molecular Entity | Approved |
| Cotempla Xr-Odt NDA #205489 |
Methylphenidate | Tablet, Orally Disintegrating, Extended Release; Oral | ORIG-1 | Neos Therap Inc | Type 3 - New Dosage Form | Approved |
| Dantrolene Sodium ANDA #204762 |
Dantrolene Sodium | Injectable; Injection | ORIG-1 | Hikma Pharms Llc | Approved | |
| Prezista NDA #021976 |
Darunavir Ethanolate | Tablet; Oral | SUPPL-45 | Janssen Prods | Labeling | Approved |
| Prezista NDA #021976 |
Darunavir Ethanolate | Tablet; Oral | SUPPL-45 | Janssen Prods | Labeling | Approved |
| Prezista NDA #202895 |
Darunavir Ethanolate | Suspension; Oral | SUPPL-20 | Janssen Prods | Labeling | Approved |
| Prezista NDA #202895 |
Darunavir Ethanolate | Suspension; Oral | SUPPL-20 | Janssen Prods | Labeling | Approved |
| Taclonex NDA #022185 |
Betamethasone Dipropionate; Calcipotriene Hydrate | Suspension; Topical | SUPPL-25 | Leo Pharma As | Manufacturing (CMC) | Approved |
June 17, 2017
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Absorica NDA #021951 |
Isotretinoin | Capsule; Oral | SUPPL-10 | Ranbaxy | REMS | Approved |
| Amnesteem ANDA #075945 |
Isotretinoin | Capsule; Oral | SUPPL-34 | Mylan Pharms Inc | REMS | Approved |
| Claravis ANDA #076135 |
Isotretinoin | Capsule; Oral | SUPPL-38 | Teva Pharms Usa | REMS | Approved |
| Claravis ANDA #076356 |
Isotretinoin | Capsule; Oral | SUPPL-35 | Teva Pharms Usa | REMS | Approved |
| Myorisan ANDA #076485 |
Isotretinoin | Capsule; Oral | SUPPL-15 | Douglas Pharms | REMS | Approved |
| Zenatane ANDA #202099 |
Isotretinoin | Capsule; Oral | SUPPL-9 | Dr Reddys Labs Ltd | REMS | Approved |
June 16, 2017
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Addyi NDA #022526 |
Flibanserin | Tablet; Oral | SUPPL-4 | Sprout Pharms | REMS | Approved |
| Aurovela 1/20 ANDA #207506 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet; Oral-21 | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Aurovela Fe 1/20 ANDA #207505 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet; Oral-28 | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Cisatracurium Besylate ANDA #205873 |
Cisatracurium Besylate | Injectable; Injection | ORIG-1 | Accord Hlthcare | Approved | |
| Cisatracurium Besylate Preservative Free ANDA #205872 |
Cisatracurium Besylate | Injectable; Injection | ORIG-1 | Accord Hlthcare | Approved | |
| Darzalex BLA #761036 |
Daratumumab | Injectable; Injection | SUPPL-5 | Janssen Biotech | Efficacy | Approved |
| Diflunisal ANDA #203547 |
Diflunisal | Tablet; Oral | ORIG-1 | Zydus Pharms Usa Inc | Approved | |
| Eletriptan Hydrobromide ANDA #206409 |
Eletriptan Hydrobromide | Tablet; Oral | ORIG-1 | Zydus Pharms Usa Inc | Approved | |
| Felbamate ANDA #206314 |
Felbamate | Suspension; Oral | ORIG-1 | Taro Pharm | Approved | |
| Her Style ANDA #207976 |
Levonorgestrel | Tablet; Oral | SUPPL-1 | Novast Labs Ltd | Labeling | Approved |
| Her Style ANDA #207976 |
Levonorgestrel | Tablet; Oral | SUPPL-2 | Novast Labs Ltd | Labeling | Approved |
| Her Style ANDA #207976 |
Levonorgestrel | Tablet; Oral | SUPPL-1 | Novast Labs Ltd | Labeling | Approved |
| Her Style ANDA #207976 |
Levonorgestrel | Tablet; Oral | SUPPL-2 | Novast Labs Ltd | Labeling | Approved |
| Lamotrigine ANDA #078947 |
Lamotrigine | Tablet; Oral | SUPPL-22 | Torrent Pharms | Labeling | Approved |
| Lamotrigine ANDA #078947 |
Lamotrigine | Tablet; Oral | SUPPL-23 | Torrent Pharms | Labeling | Approved |
| Linagliptin ANDA #208415 |
Linagliptin | Tablet; Oral | ORIG-1 | Aurobindo Pharma Ltd | Tentative Approval | |
| Neuraceq NDA #204677 |
Florbetaben F-18 | Solution; Intravenous | SUPPL-14 | Piramal Imaging | Labeling | Approved |
| Niacin ANDA #203899 |
Niacin | Tablet, Extended Release; Oral | ORIG-1 | Lannett | Approved | |
| Olanzapine ANDA #204866 |
Olanzapine | Tablet; Oral | ORIG-1 | Hikma Pharms Llc | Approved | |
| Oxycodone and Acetaminophen ANDA #201972 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-7 | Aurolife Pharma Llc | Labeling | Approved |
| Oxycodone and Acetaminophen ANDA #201972 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-7 | Aurolife Pharma Llc | Labeling | Approved |
| Propranolol Hydrochloride ANDA #070690 |
Propranolol Hydrochloride | Solution; Oral | SUPPL-21 | West-Ward Pharms Int | Labeling | Approved |
| Sklice NDA #202736 |
Ivermectin | Lotion; Topical | SUPPL-3 | Arbor Pharms Llc | Labeling | Approved |
| Synercid NDA #050747 |
Quinupristin; Dalfopristin | Injectable; Injection | SUPPL-15 | King Pharms | Labeling | Approved |
| Synercid NDA #050748 |
Dalfopristin; Quinupristin | Injectable; Iv (Infusion) | SUPPL-14 | King Pharms | Labeling | Approved |
| Tafinlar NDA #202806 |
Dabrafenib Mesylate | Capsule; Oral | SUPPL-7 | Novartis Pharms Corp | Labeling | Approved |
| Testosterone Cypionate ANDA #207742 |
Testosterone Cypionate | Injectable; Injection | ORIG-1 | Luitpold Pharms Inc | Approved | |
| Tramadol Hydrochloride and Acetaminophen ANDA #076914 |
Acetaminophen; Tramadol Hydrochloride | Tablet; Oral | SUPPL-4 | Watson Labs | Labeling | Approved |
| Xadago NDA #207145 |
Safinamide Mesylate | Tablet; Oral | SUPPL-1 | Us Worldmeds Llc | Labeling | Approved |
June 15, 2017
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Amantadine Hydrochloride ANDA #209221 |
Amantadine Hydrochloride | Capsule; Oral | ORIG-1 | Lannett Holdings Inc | Approved | |
| Aurovela 24 Fe ANDA #207504 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Aurovela Fe 1.5/30 ANDA #207580 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet; Oral-28 | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Calcium Gluconate NDA #208418 |
Calcium Gluconate | Injectable; Injection | ORIG-1 | Fresenius Kabi Usa | Type 7 - Drug Already Marketed without Approved NDA | Approved |
| Glycopyrrolate ANDA #208973 |
Glycopyrrolate | Injectable; Injection | ORIG-1 | Amneal Pharms Co | Approved | |
| Invega Sustenna NDA #022264 |
Paliperidone Palmitate | Suspension, Extended Release; Intramuscular | SUPPL-23 | Janssen Pharms | Labeling | Approved |
| Kaletra NDA #021226 |
Lopinavir; Ritonavir | Capsule; Oral | SUPPL-45 | Abbvie | Labeling | Approved |
| Kaletra NDA #021226 |
Lopinavir; Ritonavir | Capsule; Oral | SUPPL-45 | Abbvie | Labeling | Approved |
| Kaletra NDA #021251 |
Lopinavir; Ritonavir | Solution; Oral | SUPPL-54 | Abbvie | Labeling | Approved |
| Kaletra NDA #021251 |
Lopinavir; Ritonavir | Solution; Oral | SUPPL-54 | Abbvie | Labeling | Approved |
| Kaletra NDA #021906 |
Lopinavir; Ritonavir | Tablet; Oral | SUPPL-49 | Abbvie | Labeling | Approved |
| Kaletra NDA #021906 |
Lopinavir; Ritonavir | Tablet; Oral | SUPPL-49 | Abbvie | Labeling | Approved |
| Metaxalone ANDA #203695 |
Metaxalone | Tablet; Oral | ORIG-1 | Actavis Labs Fl Inc | Approved | |
| Symjepi NDA #207534 |
Epinephrine | Injectable; Injection | ORIG-1 | Adamis Pharmaceuticals Corp | Type 5 - New Formulation or New Manufacturer | Approved |
| Vfend NDA #021266 |
Voriconazole | Tablet; Oral | SUPPL-41 | Pf Prism Cv | Labeling | Approved |
| Vfend NDA #021267 |
Voriconazole | Injectable; Iv (Infusion) | SUPPL-53 | Pf Prism Cv | Labeling | Approved |
| Vfend NDA #021630 |
Voriconazole | For Suspension; Oral | SUPPL-31 | Pf Prism Cv | Labeling | Approved |
| Zoloft NDA #019839 |
Sertraline Hydrochloride | Tablet; Oral | SUPPL-88 | Pfizer | Labeling | Approved |
| Zoloft NDA #020990 |
Sertraline Hydrochloride | Concentrate; Oral | SUPPL-46 | Pfizer | Labeling | Approved |
June 23, 2017
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bevyxxa NDA #208383 |
Betrixaban | Capsule; Oral | ORIG-1 | Portola Pharma Inc | Type 1 - New Molecular Entity | Approved |
June 22, 2017
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Amantadine Hydrochloride ANDA #208107 |
Amantadine Hydrochloride | Capsule; Oral | SUPPL-2 | Watson Labs Inc | Manufacturing (CMC) | Approved |
| Hydrocodone Bitartrate and Acetaminophen ANDA #207172 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | ORIG-1 | Lannett Holdings Inc | Approved | |
| Mekinist NDA #204114 |
Trametinib Dimethyl Sulfoxide | Tablet; Oral | SUPPL-5 | Novartis Pharms Corp | Efficacy | Approved |
| Primaquine NDA #008316 |
Primaquine Phosphate | Tablet; Oral | SUPPL-23 | Sanofi Aventis Us | Labeling | Approved |
| Rituxan Hycela BLA #761064 |
Hyaluronidase;Rituximab | Injectable; Injection | ORIG-1 | Genentech Inc | Type 5 - New Formulation or New Manufacturer | Approved |
| Rituxan Hycela BLA #761064 |
Hyaluronidase;Rituximab | Injectable; Injection | SUPPL-1 | Genentech Inc | Type 5 - New Formulation or New Manufacturer | Approved |
| Simponi BLA #125289 |
Golimumab | Injectable; Injection | SUPPL-133 | Centocor Ortho Biotech Inc | Efficacy | Approved |
| Tafinlar NDA #202806 |
Dabrafenib Mesylate | Capsule; Oral | SUPPL-6 | Novartis Pharms Corp | Efficacy | Approved |
June 21, 2017
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Amantadine Hydrochloride ANDA #208966 |
Amantadine Hydrochloride | Capsule; Oral | ORIG-1 | Alembic Pharms Ltd | Approved | |
| Children's Advil NDA #020589 |
Ibuprofen | Suspension; Oral | SUPPL-35 | Pfizer | Labeling | Approved |
| Children's Advil-Flavored NDA #020589 |
Ibuprofen | Suspension; Oral | SUPPL-35 | Pfizer | Labeling | Approved |
| Daraprim NDA #008578 |
Pyrimethamine | Tablet; Oral | SUPPL-20 | Turing Pharms Llc | Labeling | Approved |
| Estrace ANDA #086069 |
Estradiol | Cream; Vaginal | SUPPL-23 | Allergan Sales Llc | Labeling | Approved |
| Granix BLA #125294 |
Tbo-Filgrastim | Injectable; Injection | SUPPL-42 | Sicor Biotech | Labeling | Approved |
| Hydrocodone Bitartrate and Acetaminophen ANDA #209036 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | ORIG-1 | Abhai Llc | Approved | |
| Hydrocodone Bitartrate and Acetaminophen ANDA #209037 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | ORIG-1 | Abhai Llc | Approved | |
| Imatinib Mesylate ANDA #204644 |
Imatinib Mesylate | Tablet; Oral | ORIG-1 | Mylan Pharms Inc | Approved | |
| Synribo NDA #203585 |
Omacetaxine Mepesuccinate | Powder; Subcutaneous | SUPPL-5 | Teva Pharms Intl | Labeling | Approved |
June 20, 2017
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acetazolamide Sodium ANDA #205358 |
Acetazolamide Sodium | Injectable; Injection | ORIG-1 | Par Sterile Products | Approved | |
| Candesartan Cilexetil ANDA #209119 |
Candesartan Cilexetil | Tablet; Oral | ORIG-1 | Alembic Pharms Ltd | Approved | |
| Hydrocodone Bitartrate and Acetaminophen ANDA #207171 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | ORIG-1 | Lannett Holdings Inc | Approved | |
| Lidocaine ANDA #206297 |
Lidocaine | Ointment; Topical | SUPPL-3 | Amneal Pharms | Manufacturing (CMC) | Approved |
| Metronidazole ANDA #208681 |
Metronidazole | Tablet; Oral | ORIG-1 | Orit Labs Llc | Approved | |
| Mydayis NDA #022063 |
Mixed Salts Of A Single-Entity Amphetamine | Capsule, Extended Release; Oral | ORIG-1 | Shire Dev Llc | Type 3 - New Dosage Form | Approved |
| Paroxetine Mesylate ANDA #207139 |
Paroxetine Mesylate | Capsule; Oral | ORIG-1 | Actavis Labs Fl Inc | Approved | |
| Piroxicam ANDA #206136 |
Piroxicam | Capsule; Oral | ORIG-1 | Pii | Approved | |
| Solifenacin Succinate ANDA #209239 |
Solifenacin Succinate | Tablet; Oral | ORIG-1 | Glenmark Pharms | Tentative Approval |
June 19, 2017
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Azithromycin ANDA #207566 |
Azithromycin | Tablet; Oral | ORIG-1 | Cspc Ouyi Pharmaceutical Co. Ltd. | Tentative Approval | |
| Baxdela NDA #208610 |
Delafloxacin | Tablet; Oral | ORIG-1 | Melinta Therapeutics Inc | Type 1 - New Molecular Entity | Approved |
| Baxdela NDA #208611 |
Delafloxacin | Injectable; Injection | ORIG-1 | Melinta Therapeutics Inc | Type 1 - New Molecular Entity | Approved |
| Cotempla Xr-Odt NDA #205489 |
Methylphenidate | Tablet, Orally Disintegrating, Extended Release; Oral | ORIG-1 | Neos Therap Inc | Type 3 - New Dosage Form | Approved |
| Dantrolene Sodium ANDA #204762 |
Dantrolene Sodium | Injectable; Injection | ORIG-1 | Hikma Pharms Llc | Approved | |
| Prezista NDA #021976 |
Darunavir Ethanolate | Tablet; Oral | SUPPL-45 | Janssen Prods | Labeling | Approved |
| Prezista NDA #021976 |
Darunavir Ethanolate | Tablet; Oral | SUPPL-45 | Janssen Prods | Labeling | Approved |
| Prezista NDA #202895 |
Darunavir Ethanolate | Suspension; Oral | SUPPL-20 | Janssen Prods | Labeling | Approved |
| Prezista NDA #202895 |
Darunavir Ethanolate | Suspension; Oral | SUPPL-20 | Janssen Prods | Labeling | Approved |
| Taclonex NDA #022185 |
Betamethasone Dipropionate; Calcipotriene Hydrate | Suspension; Topical | SUPPL-25 | Leo Pharma As | Manufacturing (CMC) | Approved |
June 17, 2017
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Absorica NDA #021951 |
Isotretinoin | Capsule; Oral | SUPPL-10 | Ranbaxy | REMS | Approved |
| Amnesteem ANDA #075945 |
Isotretinoin | Capsule; Oral | SUPPL-34 | Mylan Pharms Inc | REMS | Approved |
| Claravis ANDA #076135 |
Isotretinoin | Capsule; Oral | SUPPL-38 | Teva Pharms Usa | REMS | Approved |
| Claravis ANDA #076356 |
Isotretinoin | Capsule; Oral | SUPPL-35 | Teva Pharms Usa | REMS | Approved |
| Myorisan ANDA #076485 |
Isotretinoin | Capsule; Oral | SUPPL-15 | Douglas Pharms | REMS | Approved |
| Zenatane ANDA #202099 |
Isotretinoin | Capsule; Oral | SUPPL-9 | Dr Reddys Labs Ltd | REMS | Approved |
June 16, 2017
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Addyi NDA #022526 |
Flibanserin | Tablet; Oral | SUPPL-4 | Sprout Pharms | REMS | Approved |
| Aurovela 1/20 ANDA #207506 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet; Oral-21 | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Aurovela Fe 1/20 ANDA #207505 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet; Oral-28 | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Cisatracurium Besylate ANDA #205873 |
Cisatracurium Besylate | Injectable; Injection | ORIG-1 | Accord Hlthcare | Approved | |
| Cisatracurium Besylate Preservative Free ANDA #205872 |
Cisatracurium Besylate | Injectable; Injection | ORIG-1 | Accord Hlthcare | Approved | |
| Darzalex BLA #761036 |
Daratumumab | Injectable; Injection | SUPPL-5 | Janssen Biotech | Efficacy | Approved |
| Diflunisal ANDA #203547 |
Diflunisal | Tablet; Oral | ORIG-1 | Zydus Pharms Usa Inc | Approved | |
| Eletriptan Hydrobromide ANDA #206409 |
Eletriptan Hydrobromide | Tablet; Oral | ORIG-1 | Zydus Pharms Usa Inc | Approved | |
| Felbamate ANDA #206314 |
Felbamate | Suspension; Oral | ORIG-1 | Taro Pharm | Approved | |
| Her Style ANDA #207976 |
Levonorgestrel | Tablet; Oral | SUPPL-1 | Novast Labs Ltd | Labeling | Approved |
| Her Style ANDA #207976 |
Levonorgestrel | Tablet; Oral | SUPPL-2 | Novast Labs Ltd | Labeling | Approved |
| Her Style ANDA #207976 |
Levonorgestrel | Tablet; Oral | SUPPL-1 | Novast Labs Ltd | Labeling | Approved |
| Her Style ANDA #207976 |
Levonorgestrel | Tablet; Oral | SUPPL-2 | Novast Labs Ltd | Labeling | Approved |
| Lamotrigine ANDA #078947 |
Lamotrigine | Tablet; Oral | SUPPL-22 | Torrent Pharms | Labeling | Approved |
| Lamotrigine ANDA #078947 |
Lamotrigine | Tablet; Oral | SUPPL-23 | Torrent Pharms | Labeling | Approved |
| Linagliptin ANDA #208415 |
Linagliptin | Tablet; Oral | ORIG-1 | Aurobindo Pharma Ltd | Tentative Approval | |
| Neuraceq NDA #204677 |
Florbetaben F-18 | Solution; Intravenous | SUPPL-14 | Piramal Imaging | Labeling | Approved |
| Niacin ANDA #203899 |
Niacin | Tablet, Extended Release; Oral | ORIG-1 | Lannett | Approved | |
| Olanzapine ANDA #204866 |
Olanzapine | Tablet; Oral | ORIG-1 | Hikma Pharms Llc | Approved | |
| Oxycodone and Acetaminophen ANDA #201972 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-7 | Aurolife Pharma Llc | Labeling | Approved |
| Oxycodone and Acetaminophen ANDA #201972 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-7 | Aurolife Pharma Llc | Labeling | Approved |
| Propranolol Hydrochloride ANDA #070690 |
Propranolol Hydrochloride | Solution; Oral | SUPPL-21 | West-Ward Pharms Int | Labeling | Approved |
| Sklice NDA #202736 |
Ivermectin | Lotion; Topical | SUPPL-3 | Arbor Pharms Llc | Labeling | Approved |
| Synercid NDA #050747 |
Quinupristin; Dalfopristin | Injectable; Injection | SUPPL-15 | King Pharms | Labeling | Approved |
| Synercid NDA #050748 |
Dalfopristin; Quinupristin | Injectable; Iv (Infusion) | SUPPL-14 | King Pharms | Labeling | Approved |
| Tafinlar NDA #202806 |
Dabrafenib Mesylate | Capsule; Oral | SUPPL-7 | Novartis Pharms Corp | Labeling | Approved |
| Testosterone Cypionate ANDA #207742 |
Testosterone Cypionate | Injectable; Injection | ORIG-1 | Luitpold Pharms Inc | Approved | |
| Tramadol Hydrochloride and Acetaminophen ANDA #076914 |
Acetaminophen; Tramadol Hydrochloride | Tablet; Oral | SUPPL-4 | Watson Labs | Labeling | Approved |
| Xadago NDA #207145 |
Safinamide Mesylate | Tablet; Oral | SUPPL-1 | Us Worldmeds Llc | Labeling | Approved |
June 15, 2017
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Amantadine Hydrochloride ANDA #209221 |
Amantadine Hydrochloride | Capsule; Oral | ORIG-1 | Lannett Holdings Inc | Approved | |
| Aurovela 24 Fe ANDA #207504 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Aurovela Fe 1.5/30 ANDA #207580 |
Ethinyl Estradiol; Norethindrone Acetate | Tablet; Oral-28 | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Calcium Gluconate NDA #208418 |
Calcium Gluconate | Injectable; Injection | ORIG-1 | Fresenius Kabi Usa | Type 7 - Drug Already Marketed without Approved NDA | Approved |
| Glycopyrrolate ANDA #208973 |
Glycopyrrolate | Injectable; Injection | ORIG-1 | Amneal Pharms Co | Approved | |
| Invega Sustenna NDA #022264 |
Paliperidone Palmitate | Suspension, Extended Release; Intramuscular | SUPPL-23 | Janssen Pharms | Labeling | Approved |
| Kaletra NDA #021226 |
Lopinavir; Ritonavir | Capsule; Oral | SUPPL-45 | Abbvie | Labeling | Approved |
| Kaletra NDA #021226 |
Lopinavir; Ritonavir | Capsule; Oral | SUPPL-45 | Abbvie | Labeling | Approved |
| Kaletra NDA #021251 |
Lopinavir; Ritonavir | Solution; Oral | SUPPL-54 | Abbvie | Labeling | Approved |
| Kaletra NDA #021251 |
Lopinavir; Ritonavir | Solution; Oral | SUPPL-54 | Abbvie | Labeling | Approved |
| Kaletra NDA #021906 |
Lopinavir; Ritonavir | Tablet; Oral | SUPPL-49 | Abbvie | Labeling | Approved |
| Kaletra NDA #021906 |
Lopinavir; Ritonavir | Tablet; Oral | SUPPL-49 | Abbvie | Labeling | Approved |
| Metaxalone ANDA #203695 |
Metaxalone | Tablet; Oral | ORIG-1 | Actavis Labs Fl Inc | Approved | |
| Symjepi NDA #207534 |
Epinephrine | Injectable; Injection | ORIG-1 | Adamis Pharmaceuticals Corp | Type 5 - New Formulation or New Manufacturer | Approved |
| Vfend NDA #021266 |
Voriconazole | Tablet; Oral | SUPPL-41 | Pf Prism Cv | Labeling | Approved |
| Vfend NDA #021267 |
Voriconazole | Injectable; Iv (Infusion) | SUPPL-53 | Pf Prism Cv | Labeling | Approved |
| Vfend NDA #021630 |
Voriconazole | For Suspension; Oral | SUPPL-31 | Pf Prism Cv | Labeling | Approved |
| Zoloft NDA #019839 |
Sertraline Hydrochloride | Tablet; Oral | SUPPL-88 | Pfizer | Labeling | Approved |
| Zoloft NDA #020990 |
Sertraline Hydrochloride | Concentrate; Oral | SUPPL-46 | Pfizer | Labeling | Approved |
June 14, 2017
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Calcitriol ANDA #203289 |
Calcitriol | Capsule; Oral | ORIG-1 | Amneal Pharms | Approved | |
| Doxycycline Hyclate ANDA #208765 |
Doxycycline Hyclate | Tablet; Oral | ORIG-1 | Mayne Pharma Inc | Approved | |
| Dysport BLA #125274 |
Abobotulinumtoxina | Injectable; Injection | SUPPL-109 | Ipsen Biopharm Ltd | Efficacy | Approved |
| Prezcobix NDA #205395 |
Cobicistat; Darunavir Ethanolate | Tablet; Oral | SUPPL-4 | Janssen Prods | Labeling | Approved |
| Prezcobix NDA #205395 |
Cobicistat; Darunavir Ethanolate | Tablet; Oral | SUPPL-4 | Janssen Prods | Labeling | Approved |
June 13, 2017
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acyclovir Sodium ANDA #206606 |
Acyclovir Sodium | Injectable; Injection | ORIG-1 | Zydus Pharms Usa Inc | Approved | |
| Incruse Ellipta NDA #205382 |
Umeclidinium Bromide | Powder; Inhalation | SUPPL-6 | Glaxo Grp England | Labeling | Approved |
| Omeprazole ANDA #204661 |
Omeprazole | Capsule, Delayed Rel Pellets; Oral | ORIG-1 | Teva Pharms Usa | Approved | |
| Sevelamer Carbonate ANDA #207624 |
Sevelamer Carbonate | For Suspension; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Sular NDA #020356 |
Nisoldipine | Tablet, Extended Release; Oral | SUPPL-27 | Covis Pharma Bv | Labeling | Approved |
| Vermox NDA #017481 |
Mebendazole | Tablet, Chewable; Oral | SUPPL-47 | Janssen Pharms | Labeling | Approved |
| Zidovudine ANDA #077981 |
Zidovudine | Syrup; Oral | SUPPL-24 | Cipla Ltd | Labeling | Approved |
| Zidovudine ANDA #077981 |
Zidovudine | Syrup; Oral | SUPPL-25 | Cipla Ltd | Labeling | Approved |
June 12, 2017
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Advil NDA #201803 |
Ibuprofen Sodium | Tablet; Oral | SUPPL-8 | Pfizer Cons Hlthcare | Labeling | Approved |
| Amantadine Hydrochloride ANDA #209171 |
Amantadine Hydrochloride | Capsule; Oral | ORIG-1 | Heritage Pharma | Approved | |
| Bendamustine Hydrochloride ANDA #207149 |
Bendamustine Hydrochloride | Injectable; Injection | ORIG-1 | Wockhardt Usa | Tentative Approval | |
| Bupropion Hydrochloride ANDA #077285 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-34 | Watson Labs Inc | Labeling | Approved |
| Bupropion Hydrochloride ANDA #077285 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-34 | Watson Labs Inc | Labeling | Approved |
| Bupropion Hydrochloride ANDA #090325 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-13 | Mylan | Labeling | Approved |
| Bupropion Hydrochloride ANDA #090942 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-12 | Mylan | Labeling | Approved |
| Bupropion Hydrochloride ANDA #090942 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-13 | Mylan | Labeling | Approved |
| Bupropion Hydrochloride ANDA #090942 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-12 | Mylan | Labeling | Approved |
| Bupropion Hydrochloride ANDA #206556 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-3 | Invagen Pharms | Labeling | Approved |
| Ezetimibe ANDA #200831 |
Ezetimibe | Tablet; Oral | ORIG-1 | Watson Labs Inc | Approved | |
| Ezetimibe ANDA #203931 |
Ezetimibe | Tablet; Oral | ORIG-1 | Sandoz Inc | Approved | |
| Ezetimibe ANDA #204331 |
Ezetimibe | Tablet; Oral | ORIG-1 | Zydus Pharms Usa Inc | Approved | |
| Ezetimibe ANDA #207311 |
Ezetimibe | Tablet; Oral | ORIG-1 | Ohm Labs Inc | Approved | |
| Ezetimibe ANDA #208332 |
Ezetimibe | Tablet; Oral | ORIG-1 | Apotex Inc | Approved | |
| Ezetimibe ANDA #208803 |
Ezetimibe | Tablet; Oral | ORIG-1 | Amneal Pharms Co | Approved | |
| Intron A BLA #103132 |
Interferon Alfa-2b | Vial | SUPPL-5195 | Schering | Labeling | Approved |
| Itraconazole ANDA #208591 |
Itraconazole | Capsule; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Levetiracetam In Sodium Chloride NDA #202543 |
Levetiracetam | Injectable; Iv (Infusion) | SUPPL-10 | Hq Speciality Pharma | Labeling | Approved |
| Oxycodone Hydrochloride ANDA #204021 |
Oxycodone Hydrochloride | Tablet; Oral | ORIG-1 | Novel Labs Inc | Approved | |
| Saxagliptin ANDA #205994 |
Saxagliptin | Tablet; Oral | ORIG-1 | Glenmark Pharms | Tentative Approval |
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