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.
April 23, 2018
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Absorica
NDA #021951 |
Isotretinoin | Capsule; Oral | SUPPL-12 | Sun Pharm Inds Inc | REMS | Approved |
| Amnesteem
ANDA #075945 |
Isotretinoin | Capsule; Oral | SUPPL-36 | Mylan Pharms Inc | REMS | Approved |
| Claravis
ANDA #076135 |
Isotretinoin | Capsule; Oral | SUPPL-42 | Teva Pharms Usa | REMS | Approved |
| Claravis
ANDA #076356 |
Isotretinoin | Capsule; Oral | SUPPL-39 | Teva Pharms Usa | REMS | Approved |
| Isotretinoin
ANDA #207792 |
Isotretinoin | Capsule; Oral | SUPPL-3 | Amneal Pharms Ny | REMS | Approved |
| Myorisan
ANDA #076485 |
Isotretinoin | Capsule; Oral | SUPPL-19 | Douglas Pharms | REMS | Approved |
| Zenatane
ANDA #202099 |
Isotretinoin | Capsule; Oral | SUPPL-12 | Dr Reddys Labs Ltd | REMS | Approved |
April 20, 2018
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Amlodipine Besylate
ANDA #077073 |
Amlodipine Besylate | Tablet; Oral | SUPPL-15 | Cipla Ltd | Labeling | Approved |
| Amlodipine Besylate
ANDA #077073 |
Amlodipine Besylate | Tablet; Oral | SUPPL-15 | Cipla Ltd | Labeling | Approved |
| Amlodipine Besylate
ANDA #077073 |
Amlodipine Besylate | Tablet; Oral | SUPPL-16 | Cipla Ltd | Labeling | Approved |
| Amlodipine Besylate
ANDA #077073 |
Amlodipine Besylate | Tablet; Oral | SUPPL-15 | Cipla Ltd | Labeling | Approved |
| Amlodipine Besylate
ANDA #077073 |
Amlodipine Besylate | Tablet; Oral | SUPPL-16 | Cipla Ltd | Labeling | Approved |
| Amlodipine Besylate
ANDA #077955 |
Amlodipine Besylate | Tablet; Oral | SUPPL-14 | Invagen Pharms | Labeling | Approved |
| Bleomycin Sulfate
ANDA #205030 |
Bleomycin Sulfate | Injectable; Injection | ORIG-1 | Hong Kong | Approved | |
| Fenofibrate
ANDA #076509 |
Fenofibrate | Tablet; Oral | SUPPL-26 | Impax Labs | Labeling | Approved |
| Ferriprox
NDA #208030 |
Deferiprone | Solution; Oral | SUPPL-2 | Apopharma Inc | Efficacy | Approved |
| Micafungin
ANDA #208366 |
Micafungin | Injectable; Injection | ORIG-1 | Apotex Inc | Tentative Approval | |
| Palonosetron Hydrochloride
ANDA #205870 |
Palonosetron Hydrochloride | Injectable; Intravenous | ORIG-1 | Sagent Pharms | Tentative Approval | |
| Tafinlar
NDA #202806 |
Dabrafenib Mesylate | Capsule; Oral | SUPPL-9 | Novartis Pharms Corp | Labeling | Approved |
| Tetrabenazine
ANDA #210544 |
Tetrabenazine | Tablet; Oral | ORIG-1 | Lupin Ltd | Approved |
April 19, 2018
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acitretin
ANDA #091455 |
Acitretin | Capsule; Oral | SUPPL-10 | Barr Labs Inc | Labeling | Approved |
| Acitretin
ANDA #202552 |
Acitretin | Capsule; Oral | SUPPL-4 | Impax Labs Inc | Labeling | Approved |
| Acitretin
ANDA #202897 |
Acitretin | Capsule; Oral | SUPPL-10 | Teva Pharms Usa | Labeling | Approved |
| Acitretin
ANDA #202897 |
Acitretin | Capsule; Oral | SUPPL-10 | Teva Pharms Usa | Labeling | Approved |
| Acitretin
ANDA #204633 |
Acitretin | Capsule; Oral | SUPPL-4 | Sigmapharm Labs Llc | Labeling | Approved |
| Acitretin
ANDA #204633 |
Acitretin | Capsule; Oral | SUPPL-4 | Sigmapharm Labs Llc | Labeling | Approved |
| Akynzeo
NDA #210493 |
Fosnetupitant;Palonosetron Hydrochloride | Injectable; Injection | ORIG-1 | Helsinn Hlthcare | Type 1 - New Molecular Entity | Approved |
| Clarinex D 24 Hour
NDA #021605 |
Desloratadine; Pseudoephedrine Sulfate | Tablet, Extended Release; Oral | SUPPL-13 | Merck Sharp Dohme | Labeling | Approved |
| Clarinex-D 12 Hour
NDA #021313 |
Desloratadine; Pseudoephedrine Sulfate | Tablet, Extended Release; Oral | SUPPL-10 | Merck Sharp Dohme | Labeling | Approved |
| Dexamethasone Sodium Phosphate Preservative Free
ANDA #207442 |
Dexamethasone Sodium Phosphate | Injectable; Injection | ORIG-1 | Somerset Theraps Llc | Approved | |
| Hibistat
NDA #018300 |
Chlorhexidine Gluconate | Solution; Topical | SUPPL-19 | Molnlycke Hlth | Labeling | Approved |
| Levulan
NDA #020965 |
Aminolevulinic Acid Hydrochloride | Solution; Topical | SUPPL-16 | Dusa | Labeling | Approved |
| Soolantra
NDA #206255 |
Ivermectin | Cream; Topical | SUPPL-4 | Galderma Labs Lp | Labeling | Approved |
| Taltz
BLA #125521 |
Ixekizumab | Injectable; Injection | SUPPL-2 | Eli Lilly and Co | Approved | |
| Unasyn
NDA #050608 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-46 | Pfizer | Labeling | Approved |
April 18, 2018
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Advil Pm
NDA #021394 |
Diphenhydramine Citrate; Ibuprofen | Tablet; Oral | SUPPL-25 | Pfizer | Labeling | Approved |
| Aripiprazole
ANDA #207240 |
Aripiprazole | Tablet, Orally Disintegrating; Oral | ORIG-1 | Sciegen Pharms Inc | Approved | |
| Asacol Hd
NDA #021830 |
Mesalamine | Tablet, Delayed Release; Oral | SUPPL-12 | Apil | Labeling | Approved |
| Claritin
NDA #021952 |
Loratadine | Capsule; Oral | SUPPL-14 | Bayer Healthcare Llc | Labeling | Approved |
| Clobetasol Propionate
ANDA #210190 |
Clobetasol Propionate | Solution; Topical | ORIG-1 | Glenmark Pharms Ltd | Approved | |
| Econazole Nitrate
ANDA #210364 |
Econazole Nitrate | Cream; Topical | ORIG-1 | Mylan Pharms Inc | Approved | |
| Evotaz
NDA #206353 |
Atazanavir Sulfate; Cobicistat | Tablet; Oral | SUPPL-5 | Bristol-Myers Squibb | Labeling | Approved |
| Glucagen
NDA #020918 |
Glucagon Hydrochloride Recombinant | Injectable; Injection | SUPPL-49 | Novo Nordisk | Labeling | Approved |
| Glucagen
NDA #020918 |
Glucagon Hydrochloride Recombinant | Injectable; Injection | SUPPL-49 | Novo Nordisk | Labeling | Approved |
| Glucagen
NDA #020918 |
Glucagon Hydrochloride Recombinant | Injectable; Injection | SUPPL-49 | Novo Nordisk | Labeling | Approved |
| Glucagon
NDA #020928 |
Glucagon Recombinant | Injectable; Injection | SUPPL-55 | Lilly | Labeling | Approved |
| Glucagon
NDA #020928 |
Glucagon Recombinant | Injectable; Injection | SUPPL-55 | Lilly | Labeling | Approved |
| Glucagon
NDA #020928 |
Glucagon Recombinant | Injectable; Injection | SUPPL-55 | Lilly | Labeling | Approved |
| Lidocaine Hydrochloride
ANDA #208017 |
Lidocaine Hydrochloride | Injectable; Injection | ORIG-1 | Spectra Mdcl Devices | Approved | |
| Lupron Depot
NDA #020708 |
Leuprolide Acetate | Injectable; Injection | SUPPL-35 | Abbvie Endocrine Inc | Labeling | Approved |
| Reyataz
NDA #021567 |
Atazanavir Sulfate | Capsule; Oral | SUPPL-42 | Bristol Myers Squibb | Labeling | Approved |
| Reyataz
NDA #206352 |
Atazanavir Sulfate | Powder; Oral | SUPPL-7 | Bristol Myers Squibb | Labeling | Approved |
| Tagrisso
NDA #208065 |
Osimertinib Mesylate | Tablet; Oral | SUPPL-8 | Astrazeneca Pharms | Efficacy | Approved |
| Tagrisso
NDA #208065 |
Osimertinib Mesylate | Tablet; Oral | SUPPL-9 | Astrazeneca Pharms | Labeling | Approved |
| Treprostinil
ANDA #203649 |
Treprostinil | Injectable; Iv (Infusion), Subcutaneous | SUPPL-1 | Sandoz Inc | Manufacturing (CMC) | Approved |
| Tysabri
BLA #125104 |
Natalizumab | Vial; Single-Use | SUPPL-963 | Biogen Idec | Labeling | Approved |
| Tysabri
BLA #125104 |
Natalizumab | Vial; Single-Use | SUPPL-960 | Biogen Idec | Labeling | Approved |
| Tysabri
BLA #125104 |
Natalizumab | Vial; Single-Use | SUPPL-960 | Biogen Idec | Labeling | Approved |
| Tysabri
BLA #125104 |
Natalizumab | Vial; Single-Use | SUPPL-963 | Biogen Idec | Labeling | Approved |
April 17, 2018
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Alimta
NDA #021462 |
Pemetrexed Disodium | Injectable; Iv (Infusion) | SUPPL-52 | Lilly | Labeling | Approved |
| Capecitabine
ANDA #210604 |
Capecitabine | Tablet; Oral | ORIG-1 | Eugia Pharma | Approved | |
| Carnitor
NDA #018948 |
Levocarnitine | Solution; Oral | SUPPL-28 | Leadiant Biosci Inc | Labeling | Approved |
| Carnitor
NDA #018948 |
Levocarnitine | Tablet; Oral | SUPPL-28 | Leadiant Biosci Inc | Labeling | Approved |
| Carnitor
NDA #019257 |
Levocarnitine | Solution; Oral | SUPPL-14 | Leadiant Biosci Inc | Labeling | Approved |
| Carnitor
NDA #020182 |
Levocarnitine | Injectable; Injection | SUPPL-15 | Leadiant Biosci Inc | Labeling | Approved |
| Carnitor Sf
NDA #019257 |
Levocarnitine | Solution; Oral | SUPPL-14 | Leadiant Biosci Inc | Labeling | Approved |
| Clobetasol Propionate
ANDA #209701 |
Clobetasol Propionate | Ointment; Topical | ORIG-1 | Chemo Research Sl | Approved | |
| Clobetasol Propionate
ANDA #209974 |
Clobetasol Propionate | Cream; Topical | ORIG-1 | Teligent Pharma Inc | Approved | |
| Clobetasol Propionate
ANDA #210446 |
Clobetasol Propionate | Spray; Topical | ORIG-1 | Apotex Inc | Approved | |
| Crysvita
BLA #761068 |
Burosumab-Twza | Injectable; Injection | ORIG-1 | Ultragenyx Pharm Inc | Type 1 - New Molecular Entity | Approved |
| Diclofenac Sodium
ANDA #206411 |
Diclofenac Sodium | Solution; Topical | ORIG-1 | Zydus Pharms Usa Inc | Approved | |
| Doxazosin Mesylate
ANDA #209013 |
Doxazosin Mesylate | Tablet; Oral | ORIG-1 | Appco Pharma Llc | Approved | |
| Evoclin
NDA #050801 |
Clindamycin Phosphate | Aerosol, Foam; Topical | SUPPL-18 | Mylan Pharms Inc | Labeling | Approved |
| Ibuprofen
ANDA #209179 |
Ibuprofen | Suspension; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Irbesartan
ANDA #204740 |
Irbesartan | Tablet; Oral | ORIG-1 | Amneal Pharms | Approved | |
| Levocetirizine Dihydrochloride
ANDA #210375 |
Levocetirizine Dihydrochloride | Tablet; Oral | SUPPL-2 | Dr Reddys Labs Ltd | Manufacturing (CMC) | Approved |
| Methocarbamol
ANDA #209331 |
Methocarbamol | Solution; Im-Iv | ORIG-1 | Fresenius Kabi Usa | Approved | |
| Miglustat
ANDA #208342 |
Miglustat | Capsule; Oral | ORIG-1 | Amerigen Pharms Ltd | Approved | |
| Morphine Sulfate
ANDA #205509 |
Morphine Sulfate | Solution; Oral | ORIG-1 | Ani Pharms Inc | Approved | |
| Omnipaque 140
NDA #018956 |
Iohexol | Injectable; Injection | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 140
NDA #018956 |
Iohexol | Injectable; Injection | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 180
NDA #018956 |
Iohexol | Solution; Injection, Oral, Rectal | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 180
NDA #018956 |
Iohexol | Solution; Injection, Oral, Rectal | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 210
NDA #018956 |
Iohexol | Injectable; Injection | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 210
NDA #018956 |
Iohexol | Injectable; Injection | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 240
NDA #018956 |
Iohexol | Solution; Injection, Oral, Rectal | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 240
NDA #018956 |
Iohexol | Solution; Injection, Oral, Rectal | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 300
NDA #018956 |
Iohexol | Solution; Injection, Oral, Rectal | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 300
NDA #018956 |
Iohexol | Solution; Injection, Oral, Rectal | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 350
NDA #018956 |
Iohexol | Solution; Injection, Oral | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 350
NDA #018956 |
Iohexol | Solution; Injection, Oral | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 70
NDA #018956 |
Iohexol | Solution; Urethral | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 70
NDA #018956 |
Iohexol | Solution; Urethral | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Pioglitazone Hydrochloride
ANDA #207806 |
Pioglitazone Hydrochloride | Tablet; Oral | ORIG-1 | Prinston Inc | Approved | |
| Silodosin
ANDA #209745 |
Silodosin | Unknown | ORIG-1 | Amneal Pharms Co | Tentative Approval | |
| Sodium Nitroprusside
ANDA #210763 |
Sodium Nitroprusside | Injectable; Injection | ORIG-1 | Mylan Labs Ltd | Approved | |
| Tavalisse
NDA #209299 |
Fostamatinib | Tablet; Oral | ORIG-1 | Rigel Pharms Inc | Type 1 - New Molecular Entity | Approved |
| Tranylcypromine Sulfate
ANDA #206856 |
Tranylcypromine Sulfate | Tablet; Oral | ORIG-1 | Kinedexe Uk | Approved |
April 16, 2018
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Adenosine
ANDA #205568 |
Adenosine | Injectable; Injection | ORIG-1 | Fresenius Kabi Usa | Approved | |
| Cleocin Phosphate
NDA #050441 |
Clindamycin Phosphate | Injectable; Injection | SUPPL-79 | Pharmacia and Upjohn | Labeling | Approved |
| Cleocin Phosphate In Dextrose 5% In Plastic Container
NDA #050639 |
Clindamycin Phosphate | Injectable; Injection | SUPPL-38 | Pharmacia and Upjohn | Labeling | Approved |
| Clindamycin Phosphate
ANDA #090108 |
Clindamycin Phosphate | Injectable; Injection | SUPPL-5 | Sagent Pharms | Labeling | Approved |
| Clindamycin Phosphate
ANDA #090108 |
Clindamycin Phosphate | Injectable; Injection | SUPPL-6 | Sagent Pharms | Labeling | Approved |
| Clindamycin Phosphate
ANDA #090108 |
Clindamycin Phosphate | Injectable; Injection | SUPPL-9 | Sagent Pharms | Labeling | Approved |
| Clindamycin Phosphate
ANDA #090108 |
Clindamycin Phosphate | Injectable; Injection | SUPPL-10 | Sagent Pharms | Labeling | Approved |
| Clindamycin Phosphate
ANDA #090109 |
Clindamycin Phosphate | Injectable; Injection | SUPPL-7 | Sagent Pharms | Labeling | Approved |
| Clindamycin Phosphate
ANDA #090109 |
Clindamycin Phosphate | Injectable; Injection | SUPPL-8 | Sagent Pharms | Labeling | Approved |
| Clindamycin Phosphate
ANDA #090109 |
Clindamycin Phosphate | Injectable; Injection | SUPPL-11 | Sagent Pharms | Labeling | Approved |
| Clindamycin Phosphate
ANDA #090109 |
Clindamycin Phosphate | Injectable; Injection | SUPPL-12 | Sagent Pharms | Labeling | Approved |
| Ertapenem Sodium
ANDA #208790 |
Ertapenem Sodium | Injectable; Intramuscular, Iv (Infusion) | ORIG-1 | Acs Dobfar Spa | Approved | |
| Loratadine
ANDA #208314 |
Loratadine | Tablet; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Loratadine
ANDA #210088 |
Loratadine | Tablet, Chewable; Oral | ORIG-1 | Sun Pharma Global | Approved | |
| Opdivo
BLA #125554 |
Nivolumab | Injectable; Injection | SUPPL-58 | Bristol Myers Squibb | Efficacy | Approved |
| Tacrolimus
ANDA #210393 |
Tacrolimus | Ointment; Topical | ORIG-1 | Glenmark Pharms Ltd | Approved | |
| Tazorac
NDA #020600 |
Tazarotene | Gel; Topical | SUPPL-10 | Allergan | Labeling | Approved |
| Tygacil
NDA #021821 |
Tigecycline | Powder; Iv (Infusion) | SUPPL-45 | Pf Prism Cv | Labeling | Approved |
| Yervoy
BLA #125377 |
Ipilimumab | Injectable; Injection | SUPPL-94 | Bristol Myers Squibb | Efficacy | Approved |
April 23, 2018
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Absorica
NDA #021951 |
Isotretinoin | Capsule; Oral | SUPPL-12 | Sun Pharm Inds Inc | REMS | Approved |
| Amnesteem
ANDA #075945 |
Isotretinoin | Capsule; Oral | SUPPL-36 | Mylan Pharms Inc | REMS | Approved |
| Claravis
ANDA #076135 |
Isotretinoin | Capsule; Oral | SUPPL-42 | Teva Pharms Usa | REMS | Approved |
| Claravis
ANDA #076356 |
Isotretinoin | Capsule; Oral | SUPPL-39 | Teva Pharms Usa | REMS | Approved |
| Isotretinoin
ANDA #207792 |
Isotretinoin | Capsule; Oral | SUPPL-3 | Amneal Pharms Ny | REMS | Approved |
| Myorisan
ANDA #076485 |
Isotretinoin | Capsule; Oral | SUPPL-19 | Douglas Pharms | REMS | Approved |
| Zenatane
ANDA #202099 |
Isotretinoin | Capsule; Oral | SUPPL-12 | Dr Reddys Labs Ltd | REMS | Approved |
April 20, 2018
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Amlodipine Besylate
ANDA #077073 |
Amlodipine Besylate | Tablet; Oral | SUPPL-15 | Cipla Ltd | Labeling | Approved |
| Amlodipine Besylate
ANDA #077073 |
Amlodipine Besylate | Tablet; Oral | SUPPL-15 | Cipla Ltd | Labeling | Approved |
| Amlodipine Besylate
ANDA #077073 |
Amlodipine Besylate | Tablet; Oral | SUPPL-16 | Cipla Ltd | Labeling | Approved |
| Amlodipine Besylate
ANDA #077073 |
Amlodipine Besylate | Tablet; Oral | SUPPL-15 | Cipla Ltd | Labeling | Approved |
| Amlodipine Besylate
ANDA #077073 |
Amlodipine Besylate | Tablet; Oral | SUPPL-16 | Cipla Ltd | Labeling | Approved |
| Amlodipine Besylate
ANDA #077955 |
Amlodipine Besylate | Tablet; Oral | SUPPL-14 | Invagen Pharms | Labeling | Approved |
| Bleomycin Sulfate
ANDA #205030 |
Bleomycin Sulfate | Injectable; Injection | ORIG-1 | Hong Kong | Approved | |
| Fenofibrate
ANDA #076509 |
Fenofibrate | Tablet; Oral | SUPPL-26 | Impax Labs | Labeling | Approved |
| Ferriprox
NDA #208030 |
Deferiprone | Solution; Oral | SUPPL-2 | Apopharma Inc | Efficacy | Approved |
| Micafungin
ANDA #208366 |
Micafungin | Injectable; Injection | ORIG-1 | Apotex Inc | Tentative Approval | |
| Palonosetron Hydrochloride
ANDA #205870 |
Palonosetron Hydrochloride | Injectable; Intravenous | ORIG-1 | Sagent Pharms | Tentative Approval | |
| Tafinlar
NDA #202806 |
Dabrafenib Mesylate | Capsule; Oral | SUPPL-9 | Novartis Pharms Corp | Labeling | Approved |
| Tetrabenazine
ANDA #210544 |
Tetrabenazine | Tablet; Oral | ORIG-1 | Lupin Ltd | Approved |
April 19, 2018
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acitretin
ANDA #091455 |
Acitretin | Capsule; Oral | SUPPL-10 | Barr Labs Inc | Labeling | Approved |
| Acitretin
ANDA #202552 |
Acitretin | Capsule; Oral | SUPPL-4 | Impax Labs Inc | Labeling | Approved |
| Acitretin
ANDA #202897 |
Acitretin | Capsule; Oral | SUPPL-10 | Teva Pharms Usa | Labeling | Approved |
| Acitretin
ANDA #202897 |
Acitretin | Capsule; Oral | SUPPL-10 | Teva Pharms Usa | Labeling | Approved |
| Acitretin
ANDA #204633 |
Acitretin | Capsule; Oral | SUPPL-4 | Sigmapharm Labs Llc | Labeling | Approved |
| Acitretin
ANDA #204633 |
Acitretin | Capsule; Oral | SUPPL-4 | Sigmapharm Labs Llc | Labeling | Approved |
| Akynzeo
NDA #210493 |
Fosnetupitant;Palonosetron Hydrochloride | Injectable; Injection | ORIG-1 | Helsinn Hlthcare | Type 1 - New Molecular Entity | Approved |
| Clarinex D 24 Hour
NDA #021605 |
Desloratadine; Pseudoephedrine Sulfate | Tablet, Extended Release; Oral | SUPPL-13 | Merck Sharp Dohme | Labeling | Approved |
| Clarinex-D 12 Hour
NDA #021313 |
Desloratadine; Pseudoephedrine Sulfate | Tablet, Extended Release; Oral | SUPPL-10 | Merck Sharp Dohme | Labeling | Approved |
| Dexamethasone Sodium Phosphate Preservative Free
ANDA #207442 |
Dexamethasone Sodium Phosphate | Injectable; Injection | ORIG-1 | Somerset Theraps Llc | Approved | |
| Hibistat
NDA #018300 |
Chlorhexidine Gluconate | Solution; Topical | SUPPL-19 | Molnlycke Hlth | Labeling | Approved |
| Levulan
NDA #020965 |
Aminolevulinic Acid Hydrochloride | Solution; Topical | SUPPL-16 | Dusa | Labeling | Approved |
| Soolantra
NDA #206255 |
Ivermectin | Cream; Topical | SUPPL-4 | Galderma Labs Lp | Labeling | Approved |
| Taltz
BLA #125521 |
Ixekizumab | Injectable; Injection | SUPPL-2 | Eli Lilly and Co | Approved | |
| Unasyn
NDA #050608 |
Ampicillin Sodium; Sulbactam Sodium | Injectable; Injection | SUPPL-46 | Pfizer | Labeling | Approved |
April 18, 2018
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Advil Pm
NDA #021394 |
Diphenhydramine Citrate; Ibuprofen | Tablet; Oral | SUPPL-25 | Pfizer | Labeling | Approved |
| Aripiprazole
ANDA #207240 |
Aripiprazole | Tablet, Orally Disintegrating; Oral | ORIG-1 | Sciegen Pharms Inc | Approved | |
| Asacol Hd
NDA #021830 |
Mesalamine | Tablet, Delayed Release; Oral | SUPPL-12 | Apil | Labeling | Approved |
| Claritin
NDA #021952 |
Loratadine | Capsule; Oral | SUPPL-14 | Bayer Healthcare Llc | Labeling | Approved |
| Clobetasol Propionate
ANDA #210190 |
Clobetasol Propionate | Solution; Topical | ORIG-1 | Glenmark Pharms Ltd | Approved | |
| Econazole Nitrate
ANDA #210364 |
Econazole Nitrate | Cream; Topical | ORIG-1 | Mylan Pharms Inc | Approved | |
| Evotaz
NDA #206353 |
Atazanavir Sulfate; Cobicistat | Tablet; Oral | SUPPL-5 | Bristol-Myers Squibb | Labeling | Approved |
| Glucagen
NDA #020918 |
Glucagon Hydrochloride Recombinant | Injectable; Injection | SUPPL-49 | Novo Nordisk | Labeling | Approved |
| Glucagen
NDA #020918 |
Glucagon Hydrochloride Recombinant | Injectable; Injection | SUPPL-49 | Novo Nordisk | Labeling | Approved |
| Glucagen
NDA #020918 |
Glucagon Hydrochloride Recombinant | Injectable; Injection | SUPPL-49 | Novo Nordisk | Labeling | Approved |
| Glucagon
NDA #020928 |
Glucagon Recombinant | Injectable; Injection | SUPPL-55 | Lilly | Labeling | Approved |
| Glucagon
NDA #020928 |
Glucagon Recombinant | Injectable; Injection | SUPPL-55 | Lilly | Labeling | Approved |
| Glucagon
NDA #020928 |
Glucagon Recombinant | Injectable; Injection | SUPPL-55 | Lilly | Labeling | Approved |
| Lidocaine Hydrochloride
ANDA #208017 |
Lidocaine Hydrochloride | Injectable; Injection | ORIG-1 | Spectra Mdcl Devices | Approved | |
| Lupron Depot
NDA #020708 |
Leuprolide Acetate | Injectable; Injection | SUPPL-35 | Abbvie Endocrine Inc | Labeling | Approved |
| Reyataz
NDA #021567 |
Atazanavir Sulfate | Capsule; Oral | SUPPL-42 | Bristol Myers Squibb | Labeling | Approved |
| Reyataz
NDA #206352 |
Atazanavir Sulfate | Powder; Oral | SUPPL-7 | Bristol Myers Squibb | Labeling | Approved |
| Tagrisso
NDA #208065 |
Osimertinib Mesylate | Tablet; Oral | SUPPL-8 | Astrazeneca Pharms | Efficacy | Approved |
| Tagrisso
NDA #208065 |
Osimertinib Mesylate | Tablet; Oral | SUPPL-9 | Astrazeneca Pharms | Labeling | Approved |
| Treprostinil
ANDA #203649 |
Treprostinil | Injectable; Iv (Infusion), Subcutaneous | SUPPL-1 | Sandoz Inc | Manufacturing (CMC) | Approved |
| Tysabri
BLA #125104 |
Natalizumab | Vial; Single-Use | SUPPL-963 | Biogen Idec | Labeling | Approved |
| Tysabri
BLA #125104 |
Natalizumab | Vial; Single-Use | SUPPL-960 | Biogen Idec | Labeling | Approved |
| Tysabri
BLA #125104 |
Natalizumab | Vial; Single-Use | SUPPL-960 | Biogen Idec | Labeling | Approved |
| Tysabri
BLA #125104 |
Natalizumab | Vial; Single-Use | SUPPL-963 | Biogen Idec | Labeling | Approved |
April 17, 2018
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Alimta
NDA #021462 |
Pemetrexed Disodium | Injectable; Iv (Infusion) | SUPPL-52 | Lilly | Labeling | Approved |
| Capecitabine
ANDA #210604 |
Capecitabine | Tablet; Oral | ORIG-1 | Eugia Pharma | Approved | |
| Carnitor
NDA #018948 |
Levocarnitine | Solution; Oral | SUPPL-28 | Leadiant Biosci Inc | Labeling | Approved |
| Carnitor
NDA #018948 |
Levocarnitine | Tablet; Oral | SUPPL-28 | Leadiant Biosci Inc | Labeling | Approved |
| Carnitor
NDA #019257 |
Levocarnitine | Solution; Oral | SUPPL-14 | Leadiant Biosci Inc | Labeling | Approved |
| Carnitor
NDA #020182 |
Levocarnitine | Injectable; Injection | SUPPL-15 | Leadiant Biosci Inc | Labeling | Approved |
| Carnitor Sf
NDA #019257 |
Levocarnitine | Solution; Oral | SUPPL-14 | Leadiant Biosci Inc | Labeling | Approved |
| Clobetasol Propionate
ANDA #209701 |
Clobetasol Propionate | Ointment; Topical | ORIG-1 | Chemo Research Sl | Approved | |
| Clobetasol Propionate
ANDA #209974 |
Clobetasol Propionate | Cream; Topical | ORIG-1 | Teligent Pharma Inc | Approved | |
| Clobetasol Propionate
ANDA #210446 |
Clobetasol Propionate | Spray; Topical | ORIG-1 | Apotex Inc | Approved | |
| Crysvita
BLA #761068 |
Burosumab-Twza | Injectable; Injection | ORIG-1 | Ultragenyx Pharm Inc | Type 1 - New Molecular Entity | Approved |
| Diclofenac Sodium
ANDA #206411 |
Diclofenac Sodium | Solution; Topical | ORIG-1 | Zydus Pharms Usa Inc | Approved | |
| Doxazosin Mesylate
ANDA #209013 |
Doxazosin Mesylate | Tablet; Oral | ORIG-1 | Appco Pharma Llc | Approved | |
| Evoclin
NDA #050801 |
Clindamycin Phosphate | Aerosol, Foam; Topical | SUPPL-18 | Mylan Pharms Inc | Labeling | Approved |
| Ibuprofen
ANDA #209179 |
Ibuprofen | Suspension; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Irbesartan
ANDA #204740 |
Irbesartan | Tablet; Oral | ORIG-1 | Amneal Pharms | Approved | |
| Levocetirizine Dihydrochloride
ANDA #210375 |
Levocetirizine Dihydrochloride | Tablet; Oral | SUPPL-2 | Dr Reddys Labs Ltd | Manufacturing (CMC) | Approved |
| Methocarbamol
ANDA #209331 |
Methocarbamol | Solution; Im-Iv | ORIG-1 | Fresenius Kabi Usa | Approved | |
| Miglustat
ANDA #208342 |
Miglustat | Capsule; Oral | ORIG-1 | Amerigen Pharms Ltd | Approved | |
| Morphine Sulfate
ANDA #205509 |
Morphine Sulfate | Solution; Oral | ORIG-1 | Ani Pharms Inc | Approved | |
| Omnipaque 140
NDA #018956 |
Iohexol | Injectable; Injection | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 140
NDA #018956 |
Iohexol | Injectable; Injection | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 180
NDA #018956 |
Iohexol | Solution; Injection, Oral, Rectal | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 180
NDA #018956 |
Iohexol | Solution; Injection, Oral, Rectal | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 210
NDA #018956 |
Iohexol | Injectable; Injection | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 210
NDA #018956 |
Iohexol | Injectable; Injection | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 240
NDA #018956 |
Iohexol | Solution; Injection, Oral, Rectal | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 240
NDA #018956 |
Iohexol | Solution; Injection, Oral, Rectal | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 300
NDA #018956 |
Iohexol | Solution; Injection, Oral, Rectal | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 300
NDA #018956 |
Iohexol | Solution; Injection, Oral, Rectal | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 350
NDA #018956 |
Iohexol | Solution; Injection, Oral | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 350
NDA #018956 |
Iohexol | Solution; Injection, Oral | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 70
NDA #018956 |
Iohexol | Solution; Urethral | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Omnipaque 70
NDA #018956 |
Iohexol | Solution; Urethral | SUPPL-101 | Ge Healthcare | Labeling | Approved |
| Pioglitazone Hydrochloride
ANDA #207806 |
Pioglitazone Hydrochloride | Tablet; Oral | ORIG-1 | Prinston Inc | Approved | |
| Silodosin
ANDA #209745 |
Silodosin | Unknown | ORIG-1 | Amneal Pharms Co | Tentative Approval | |
| Sodium Nitroprusside
ANDA #210763 |
Sodium Nitroprusside | Injectable; Injection | ORIG-1 | Mylan Labs Ltd | Approved | |
| Tavalisse
NDA #209299 |
Fostamatinib | Tablet; Oral | ORIG-1 | Rigel Pharms Inc | Type 1 - New Molecular Entity | Approved |
| Tranylcypromine Sulfate
ANDA #206856 |
Tranylcypromine Sulfate | Tablet; Oral | ORIG-1 | Kinedexe Uk | Approved |
April 16, 2018
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Adenosine
ANDA #205568 |
Adenosine | Injectable; Injection | ORIG-1 | Fresenius Kabi Usa | Approved | |
| Cleocin Phosphate
NDA #050441 |
Clindamycin Phosphate | Injectable; Injection | SUPPL-79 | Pharmacia and Upjohn | Labeling | Approved |
| Cleocin Phosphate In Dextrose 5% In Plastic Container
NDA #050639 |
Clindamycin Phosphate | Injectable; Injection | SUPPL-38 | Pharmacia and Upjohn | Labeling | Approved |
| Clindamycin Phosphate
ANDA #090108 |
Clindamycin Phosphate | Injectable; Injection | SUPPL-5 | Sagent Pharms | Labeling | Approved |
| Clindamycin Phosphate
ANDA #090108 |
Clindamycin Phosphate | Injectable; Injection | SUPPL-6 | Sagent Pharms | Labeling | Approved |
| Clindamycin Phosphate
ANDA #090108 |
Clindamycin Phosphate | Injectable; Injection | SUPPL-9 | Sagent Pharms | Labeling | Approved |
| Clindamycin Phosphate
ANDA #090108 |
Clindamycin Phosphate | Injectable; Injection | SUPPL-10 | Sagent Pharms | Labeling | Approved |
| Clindamycin Phosphate
ANDA #090109 |
Clindamycin Phosphate | Injectable; Injection | SUPPL-7 | Sagent Pharms | Labeling | Approved |
| Clindamycin Phosphate
ANDA #090109 |
Clindamycin Phosphate | Injectable; Injection | SUPPL-8 | Sagent Pharms | Labeling | Approved |
| Clindamycin Phosphate
ANDA #090109 |
Clindamycin Phosphate | Injectable; Injection | SUPPL-11 | Sagent Pharms | Labeling | Approved |
| Clindamycin Phosphate
ANDA #090109 |
Clindamycin Phosphate | Injectable; Injection | SUPPL-12 | Sagent Pharms | Labeling | Approved |
| Ertapenem Sodium
ANDA #208790 |
Ertapenem Sodium | Injectable; Intramuscular, Iv (Infusion) | ORIG-1 | Acs Dobfar Spa | Approved | |
| Loratadine
ANDA #208314 |
Loratadine | Tablet; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Loratadine
ANDA #210088 |
Loratadine | Tablet, Chewable; Oral | ORIG-1 | Sun Pharma Global | Approved | |
| Opdivo
BLA #125554 |
Nivolumab | Injectable; Injection | SUPPL-58 | Bristol Myers Squibb | Efficacy | Approved |
| Tacrolimus
ANDA #210393 |
Tacrolimus | Ointment; Topical | ORIG-1 | Glenmark Pharms Ltd | Approved | |
| Tazorac
NDA #020600 |
Tazarotene | Gel; Topical | SUPPL-10 | Allergan | Labeling | Approved |
| Tygacil
NDA #021821 |
Tigecycline | Powder; Iv (Infusion) | SUPPL-45 | Pf Prism Cv | Labeling | Approved |
| Yervoy
BLA #125377 |
Ipilimumab | Injectable; Injection | SUPPL-94 | Bristol Myers Squibb | Efficacy | Approved |
April 13, 2018
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Antivert
NDA #010721 |
Meclizine Hydrochloride | Tablet, Chewable; Oral | SUPPL-61 | Casper Pharma Llc | Efficacy | Approved |
| Antivert
NDA #010721 |
Meclizine Hydrochloride | Tablet; Oral | SUPPL-61 | Casper Pharma Llc | Efficacy | Approved |
| Definity
NDA #021064 |
Perflutren | Injectable; Intravenous | SUPPL-21 | Lantheus Medcl | Manufacturing (CMC) | Approved |
| Kevzara
BLA #761037 |
Sarilumab | Injectable; Injection | SUPPL-1 | Sanofi Synthelabo | Efficacy | Approved |
| Nulojix
BLA #125288 |
Belatacept | Injectable; Injection | SUPPL-75 | Bristol Myers Squibb | Efficacy | Approved |
| Pravastatin Sodium
ANDA #209869 |
Pravastatin Sodium | Tablet; Oral | ORIG-1 | Appco Pharma Llc | Approved | |
| Prevacid
NDA #020406 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-84 | Takeda Pharms Usa | Labeling | Approved |
| Prevacid
NDA #021428 |
Lansoprazole | Tablet, Orally Disintegrating, Delayed Release; Oral | SUPPL-32 | Takeda Pharms Usa | Labeling | Approved |
| Testosterone
ANDA #208560 |
Testosterone | Gel; Topical | ORIG-1 | Lupin Atlantis | Tentative Approval | |
| Varubi
NDA #206500 |
Rolapitant Hydrochloride | Tablet; Oral | SUPPL-3 | Tesaro Inc | Labeling | Approved |
| Varubi
NDA #208399 |
Rolapitant Hydrochloride | Emulsion; Iv (Infusion) | SUPPL-2 | Tesaro Inc | Labeling | Approved |
| Viberzi
NDA #206940 |
Eluxadoline | Tablet; Oral | SUPPL-3 | Allergan Holdings | Labeling | Approved |
| Viberzi
NDA #206940 |
Eluxadoline | Tablet; Oral | SUPPL-3 | Allergan Holdings | Labeling | Approved |
April 12, 2018
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Advil
NDA #201803 |
Ibuprofen Sodium | Tablet; Oral | SUPPL-11 | Pfizer Cons Hlthcare | Labeling | Approved |
| Everolimus
ANDA #206133 |
Everolimus | Tablet; Oral | ORIG-1 | West-Ward Pharms Int | Approved | |
| Netspot
NDA #208547 |
Gallium Dotatate Ga-68 | Powder; Intravenous | SUPPL-11 | Aaa Usa Inc | Labeling | Approved |
| Praxbind
BLA #761025 |
Idarucizumab | Injectable; Injection | SUPPL-2 | Boehringer Ingelheim | Efficacy | Approved |
| Syndros
NDA #205525 |
Dronabinol | Solution; Oral | SUPPL-5 | Insys Dev Co Inc | Labeling | Approved |
April 11, 2018
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Candesartan Cilexetil and Hydrochlorothiazide
ANDA #207455 |
Candesartan Cilexetil; Hydrochlorothiazide | Tablet; Oral | ORIG-1 | Prinston Inc | Approved | |
| Cyproheptadine Hydrochloride
ANDA #209172 |
Cyproheptadine Hydrochloride | Tablet; Oral | ORIG-1 | Strides Pharma | Approved | |
| Daptomycin
ANDA #206077 |
Daptomycin | Powder; Intravenous | ORIG-1 | Fresenius Kabi Usa | Approved | |
| Docetaxel
NDA #203551 |
Docetaxel | Injectable; Injection | SUPPL-5 | Actavis Llc | Labeling | Approved |
| Docetaxel
NDA #203551 |
Docetaxel | Injectable; Injection | SUPPL-5 | Actavis Llc | Labeling | Approved |
| Dopamine Hydrochloride
ANDA #207707 |
Dopamine Hydrochloride | Injectable; Injection | ORIG-1 | Hikma Intl Pharms | Approved | |
| Flac
ANDA #210736 |
Fluocinolone Acetonide | Oil/Drops; Otic | ORIG-1 | Patrin Pharma Inc | Approved | |
| Ibuprofen
ANDA #079174 |
Ibuprofen | Tablet; Oral | SUPPL-14 | Granules India | Labeling | Approved |
| Ibuprofen
ANDA #079174 |
Ibuprofen | Tablet; Oral | SUPPL-10 | Granules India | Manufacturing (CMC) | Approved |
| Ibuprofen
ANDA #079174 |
Ibuprofen | Tablet; Oral | SUPPL-14 | Granules India | Labeling | Approved |
| Ibuprofen
ANDA #079174 |
Ibuprofen | Tablet; Oral | SUPPL-10 | Granules India | Manufacturing (CMC) | Approved |
| Loratadine
ANDA #208477 |
Loratadine | Tablet, Orally Disintegrating; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Metro I.V. In Plastic Container
NDA #018900 |
Metronidazole | Injectable; Injection | SUPPL-35 | B Braun | Labeling | Approved |
| Semprex-D
NDA #019806 |
Acrivastine; Pseudoephedrine Hydrochloride | Capsule; Oral | SUPPL-13 | Auxilium Pharms Llc | Labeling | Approved |
April 10, 2018
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Afinitor
NDA #022334 |
Everolimus | Tablet; Oral | SUPPL-40 | Novartis | Efficacy | Approved |
| Afinitor Disperz
NDA #203985 |
Everolimus | Tablet, For Suspension; Oral | SUPPL-13 | Novartis Pharm | Efficacy | Approved |
| Blincyto
BLA #125557 |
Blinatumomab | Injectable; Injection | SUPPL-14 | Amgen | Manufacturing (CMC) | Approved |
| Celestone Soluspan
NDA #014602 |
Betamethasone Acetate; Betamethasone Sodium Phosphate | Injectable; Injection | SUPPL-62 | Merck Sharp Dohme | Labeling | Approved |
| Dofetilide
ANDA #208625 |
Dofetilide | Capsule; Oral | ORIG-1 | Apicore Us | Approved | |
| Dupixent
BLA #761055 |
Dupilumab | Injectable; Injection | SUPPL-3 | Regeneron Pharmaceuticals | Efficacy | Approved |
| Lamivudine and Zidovudine
ANDA #206375 |
Lamivudine; Zidovudine | Tablet; Oral | ORIG-1 | Shanghai Desano | Approved | |
| Metformin Hydrochloride; Sitagliptin Phosphate
ANDA #205078 |
Metformin Hydrochloride;Sitagliptin Phosphate | Unknown | ORIG-1 | Sun Pharma Global | Tentative Approval |
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