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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Phenobarbital 15 mg Tablets, USP by C.O. Truxton: Recall - Labeling Error on Declared Strength
- Complete and submit the report Online:www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women
- National Drug Code Directory
- Use of Codeine and Tramadol Products in Breastfeeding Women - Questions and Answers (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
- 11th Annual FDA/DIA Statistics Forum, April 24-26, 2017
April 20, 2017
Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Botox BLA #103000 | Onabotulinumtoxina | Vial; Single-Use | SUPPL-5302 | Allergan | LABELING | Approved |
Botox Cosmetic BLA #103000 | Onabotulinumtoxina | Vial; Single-Use | SUPPL-5302 | Allergan | LABELING | Approved |
Clindamycin In 0.9%Sodium Chloride NDA #208083 | Clindamycin; Sodium Chloride | Injectable; Intravenous | ORIG-1 | Celerity Pharms Llc | TYPE 5 | Approved |
April 19, 2017
Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Cefuroxime Axetil ANDA #065496 | Cefuroxime Axetil | Tablet; Oral | SUPPL-6 | Alkem Labs Ltd | MANUF (CMC) | Approved |
Dabigatran Etexilate ANDA #208057 | Dabigatran Etexilate | Capsule; Oral | ORIG-1 | Teva Pharms Usa | Tentative Approval | |
Dexlansoprazole ANDA #202294 | Dexlansoprazole | Capsule, Delayed Release; Oral | ORIG-1 | Par Pharm Inc | Approved | |
Probuphine NDA #204442 | Buprenorphine Hydrochloride | Implant; Implantation | SUPPL-3 | Braeburn Pharms Inc | REMS | Approved |
Xyrem NDA #021196 | Sodium Oxybate | Solution; Oral | SUPPL-26 | Jazz Pharms | MANUF (CMC) | Approved |
April 18, 2017
Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
---|---|---|---|---|---|---|
Alendronate Sodium ANDA #090258 | Alendronate Sodium | Tablet; Oral | SUPPL-10 | Austarpharma Llc | MANUF (CMC) | Approved |
Cetylev NDA #207916 | Acetylcysteine | Tablet, Effervescent; Oral | SUPPL-3 | Arbor Pharms Llc | LABELING | Approved |
Dabigatran Etexilate ANDA #207984 | Dabigatran Etexilate | Capsule; Oral | ORIG-1 | Glenmark Pharms Ltd | Tentative Approval | |
Eptifibatide ANDA #204589 | Eptifibatide | Injectable; Injection | ORIG-1 | Akorn | Approved | |
Etomidate ANDA #209058 | Etomidate | Injectable; Injection | ORIG-1 | Gland Pharma Ltd | Approved | |
Fluticasone Propionate ANDA #077538 | Fluticasone Propionate | Spray, Metered; Nasal | SUPPL-15 | Apotex Inc | LABELING | Approved |
Fluticasone Propionate ANDA #077538 | Fluticasone Propionate | Spray, Metered; Nasal | SUPPL-19 | Apotex Inc | MANUF (CMC) | Approved |
Glipizide ANDA #075795 | Glipizide | Tablet; Oral | SUPPL-13 | Apotex | LABELING | Approved |
Ibuprofen ANDA #076925 | Ibuprofen | Suspension; Oral | SUPPL-36 | Perrigo R and D | LABELING | Approved |
Lopid NDA #018422 | Gemfibrozil | Capsule; Oral | SUPPL-56 | Pfizer Pharms | LABELING | Approved |
Lopid NDA #018422 | Gemfibrozil | Tablet; Oral | SUPPL-56 | Pfizer Pharms | LABELING | Approved |
Montelukast Sodium ANDA #209011 | Montelukast Sodium | Tablet, Chewable; Oral | ORIG-1 | Cspc Ouyi Pharm Co | Approved | |
Temozolomide ANDA #203959 | Temozolomide | Capsule; Oral | ORIG-1 | Watson Labs Teva | Approved |
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