What's New on the FDA Drugs Site
July 27, 2017
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages
- Atenolol Tablets (New - Currently in Shortage)
- Azithromycin Tablets (New - Discontinuation)
- Sertraline Hydrochloride Tablets (New - Discontinuation)
- Spironolactone Tablets (New - Discontinuation)
- National Drug Code Directory
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
New and Generic Drug Approvals
July 27, 2017
Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Abilify Maintena Kit NDA #202971 | Aripiprazole | For Suspension, Extended Release; Intramuscular | SUPPL-10 | Otsuka Pharm Co Ltd | Efficacy | Approved |
Aciphex Sprinkle NDA #204736 | Rabeprazole Sodium | Capsule, Delayed Release; Oral | SUPPL-8 | Fsc Therap | Labeling | Approved |
Apriso NDA #022301 | Mesalamine | Capsule, Extended Release; Oral | SUPPL-9 | Valeant Pharms Intl | Labeling | Approved |
Asacol Hd NDA #021830 | Mesalamine | Tablet, Delayed Release; Oral | SUPPL-11 | Apil | Labeling | Approved |
Asacol NDA #019651 | Mesalamine | Tablet, Delayed Release; Oral | SUPPL-27 | Apil | Labeling | Approved |
Canasa NDA #021252 | Mesalamine | Suppository; Rectal | SUPPL-23 | Forest Labs Llc | Labeling | Approved |
Delzicol NDA #204412 | Mesalamine | Capsule, Delayed Release; Oral | SUPPL-8 | Apil | Labeling | Approved |
Keytruda BLA #125514 | Pembrolizumab | Powder, For Injection Solution, Lyophilized Powder | SUPPL-19 | Merck Sharp Dohme | Labeling | Approved |
Keytruda BLA #125514 | Pembrolizumab | Powder, For Injection Solution, Lyophilized Powder | SUPPL-19 | Merck Sharp Dohme | Labeling | Approved |
Keytruda BLA #125514 | Pembrolizumab | Powder, For Injection Solution, Lyophilized Powder | SUPPL-23 | Merck Sharp Dohme | Labeling | Approved |
Lialda NDA #022000 | Mesalamine | Tablet, Delayed Release; Oral | SUPPL-16 | Shire | Labeling | Approved |
Minoxidil (For Men) ANDA #208092 | Minoxidil | Aerosol, Foam; Topical | ORIG-2 | Watson Labs Inc | Approved | |
Pentasa NDA #020049 | Mesalamine | Capsule, Extended Release; Oral | SUPPL-30 | Shire | Labeling | Approved |
Rowasa NDA #019618 | Mesalamine | Enema; Rectal | SUPPL-23 | Mylan Speciality Lp | Labeling | Approved |
Rowasa NDA #019618 | Mesalamine | Enema; Rectal | SUPPL-23 | Mylan Speciality Lp | Labeling | Approved |
Sfrowasa NDA #019618 | Mesalamine | Enema; Rectal | SUPPL-23 | Mylan Speciality Lp | Labeling | Approved |
Sfrowasa NDA #019618 | Mesalamine | Enema; Rectal | SUPPL-23 | Mylan Speciality Lp | Labeling | Approved |
Ultravist 150 NDA #020220 | Iopromide | Injectable; Injection | SUPPL-43 | Bayer Hlthcare | Labeling | Approved |
Ultravist 240 NDA #020220 | Iopromide | Injectable; Injection | SUPPL-43 | Bayer Hlthcare | Labeling | Approved |
Ultravist 300 In Plastic Container NDA #020220 | Iopromide | Injectable; Injection | SUPPL-43 | Bayer Hlthcare | Labeling | Approved |
Ultravist 300 NDA #020220 | Iopromide | Injectable; Injection | SUPPL-43 | Bayer Hlthcare | Labeling | Approved |
Ultravist 370 NDA #020220 | Iopromide | Injectable; Injection | SUPPL-43 | Bayer Hlthcare | Labeling | Approved |
July 26, 2017
Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Cipro In Dextrose 5% In Plastic Container NDA #019857 | Ciprofloxacin | Injectable; Injection | SUPPL-66 | Bayer Hlthcare | Labeling | Approved |
Cipro NDA #019537 | Ciprofloxacin Hydrochloride | Tablet; Oral | SUPPL-87 | Bayer Hlthcare | Labeling | Approved |
Cipro NDA #020780 | Ciprofloxacin | For Suspension; Oral | SUPPL-44 | Bayer Hlthcare | Labeling | Approved |
Cipro Xr NDA #021473 | Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-38 | Bayer Hlthcare | Labeling | Approved |
Exemestane ANDA #209208 | Exemestane | Tablet; Oral | ORIG-1 | Upsher-Smith Labs | Approved | |
Fycompa NDA #202834 | Perampanel | Tablet; Oral | SUPPL-12 | Eisai Inc | Efficacy | Approved |
Fycompa NDA #208277 | Perampanel | Suspension; Oral | SUPPL-1 | Eisai Inc | Efficacy | Approved |
Naloxone Hydrochloride ANDA #207634 | Naloxone Hydrochloride | Injectable; Injection | ORIG-1 | Somerset Theraps Llc | Approved | |
Nityr NDA #209449 | Nitisinone | Tablet; Oral | ORIG-1 | Cycle Pharms Ltd | Type 5 - New Formulation or New Manufacturer | Approved |
Olopatadine Hydrochloride ANDA #206046 | Olopatadine Hydrochloride | Solution/Drops; Ophthalmic | ORIG-1 | Cipla Ltd | Approved | |
Qnasl NDA #202813 | Beclomethasone Dipropionate | Aerosol, Metered; Nasal | SUPPL-11 | Teva Branded Pharm | Labeling | Approved |
Qnasl NDA #202813 | Beclomethasone Dipropionate | Aerosol, Metered; Nasal | SUPPL-11 | Teva Branded Pharm | Labeling | Approved |
Vibra-Tabs NDA #050533 | Doxycycline Hyclate | Tablet; Oral | SUPPL-45 | Pfizer | Labeling | Approved |
Vibramycin NDA #050006 | Doxycycline | For Suspension; Oral | SUPPL-89 | Pfizer | Labeling | Approved |
Vibramycin NDA #050007 | Doxycycline Hyclate | Capsule; Oral | SUPPL-32 | Pfizer | Labeling | Approved |
Vibramycin NDA #050442 | Doxycycline Hyclate | Injectable; Injection | SUPPL-20 | Pfizer | Labeling | Approved |
Vibramycin NDA #050480 | Doxycycline Calcium | Suspension; Oral | SUPPL-56 | Pfizer | Labeling | Approved |
Victoza NDA #022341 | Liraglutide Recombinant | Solution; Subcutaneous | SUPPL-29 | Novo Nordisk Inc | REMS | Approved |
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Friday, July 28, 2017
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