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21,477 catalysts · 4,728 grant · 3,831 device 510k · 3,286 8k filing · 3,041 approval · 2,000 device pma · 2,000 device recall
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21,477 catalysts · 4,728 grant · 3,831 device 510k · 3,286 8k filing · 3,041 approval · 2,000 device pma · 2,000 device recall
Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL
Sponsor: HIKMA. Form: TABLET. Route: ORAL
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: EBG. Advisory committee: Dental. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: KTT. Advisory committee: Orthopedic. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: HIS. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Special
Product code: OAS. Advisory committee: Radiology. Type: Special
Product code: LYC. Advisory committee: Dental. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: FRG. Advisory committee: General Hospital. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Traditional
Product code: NPR. Advisory committee: Hematology. Type: Special
Product code: DZJ. Advisory committee: Dental. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Abbreviated
Product code: FRG. Advisory committee: General Hospital. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: POK. Advisory committee: Radiology. Type: Traditional
Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION
Sponsor: MSN. Form: TABLET, DELAYED RELEASE. Route: ORAL
Sponsor: SEBELA WOMENS HLTH. Form: SYSTEM. Route: INTRAUTERINE
Product code: FRG. Advisory committee: General Hospital. Type: Traditional
Product code: LZC. Advisory committee: General Hospital. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: NRY. Advisory committee: Cardiovascular. Type: Traditional
Product code: MQB. Advisory committee: Radiology. Type: Traditional
Product code: QJI. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: QKB. Advisory committee: Radiology. Type: Traditional
Product code: OHV. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: BAYER HLTHCARE. Form: TABLET. Route: ORAL
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: SDY. Advisory committee: Cardiovascular. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Special
Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional
Product code: MUJ. Advisory committee: Radiology. Type: Traditional
Product code: GDW. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Special
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
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing