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3,934 catalysts · 4,728 grant · 3,734 device 510k · 3,603 8k filing · 3,018 approval · 2,000 device pma · 2,000 device recall
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3,934 catalysts · 4,728 grant · 3,734 device 510k · 3,603 8k filing · 3,018 approval · 2,000 device pma · 2,000 device recall
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Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION
Sponsor: ELITE LABS INC. Form: TABLET. Route: ORAL
Sponsor: ASCENT PHARMS INC. Form: TABLET. Route: ORAL
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15 — Reason: Out of Specification for Dissolution — Status: Ongoing
Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL
Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: CHIESI. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: PFIZER. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL
Sponsor: PFIZER. Form: SOLUTION. Route: ORAL
Sponsor: NATCO PHARMA LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: AMNEAL PHARMS CO. Form: TABLET. Route: ORAL
Sponsor: PH HEALTH. Form: TABLET. Route: ORAL
Sponsor: ACTELION. Form: TABLET. Route: ORAL
Sponsor: NATCO PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: ACTELION. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION
Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION
Sponsor: RUBICON RESEARCH. Form: TABLET. Route: SUBLINGUAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL
Sponsor: SUN PHARM. Form: TABLET. Route: SUBLINGUAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: SUBLINGUAL
Sponsor: RHODES PHARMS. Form: TABLET. Route: SUBLINGUAL
Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL
Sponsor: SUN PHARM. Form: TABLET. Route: SUBLINGUAL
Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL
Sponsor: WES PHARMA INC. Form: TABLET. Route: SUBLINGUAL
Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL
Sponsor: ALKEM LABS LTD. Form: TABLET. Route: SUBLINGUAL
Sponsor: INDIVIOR. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS
Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL
Sponsor: RHODES PHARMS. Form: TABLET. Route: SUBLINGUAL
Sponsor: INDIVIOR. Form: FILM. Route: BUCCAL, SUBLINGUAL
Sponsor: BARR. Form: TABLET. Route: SUBLINGUAL
Sponsor: EDENBRIDGE PHARMS. Form: TABLET. Route: SUBLINGUAL
Sponsor: SPECGX LLC. Form: TABLET. Route: SUBLINGUAL
Sponsor: LANNETT CO INC. Form: TABLET. Route: SUBLINGUAL
Sponsor: AMNEAL PHARMS. Form: TABLET. Route: SUBLINGUAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL
Sponsor: HIKMA. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION
Sponsor: MSN. Form: TABLET, DELAYED RELEASE. Route: ORAL
Sponsor: SEBELA WOMENS HLTH. Form: SYSTEM. Route: INTRAUTERINE
Sponsor: BAYER HLTHCARE. Form: TABLET. Route: ORAL
Sponsor: SAPTALIS PHARMS. Form: CONCENTRATE. Route: ORAL
Sponsor: SHORLA. Form: SOLUTION. Route: INTRAVENOUS
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6007-61 — Reason: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. — Status: Ongoing