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22,375 catalysts · 4,728 grant · 4,406 device 510k · 3,310 8k filing · 3,188 approval · 2,000 device pma · 2,000 device recall
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22,375 catalysts · 4,728 grant · 4,406 device 510k · 3,310 8k filing · 3,188 approval · 2,000 device pma · 2,000 device recall
Product code: QOF. Advisory committee: Microbiology. Type: Dual Track
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: EMA. Advisory committee: Dental. Type: Traditional
Product code: OLI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FMI. Advisory committee: General Hospital. Type: Special
Product code: PCH. Advisory committee: Microbiology. Type: Traditional
Product code: JMT. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Special
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: KNW. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: PRE. Advisory committee: Microbiology. Type: Traditional
Product code: HGM. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: JAQ. Advisory committee: Radiology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: LCJ. Advisory committee: Unknown. Type: Special
Sponsor: TORRENT. Form: TABLET. Route: ORAL
Product code: IRP. Advisory committee: Physical Medicine. Type: Special
Product code: NOU. Advisory committee: Anesthesiology. Type: Traditional
Product code: SCA. Advisory committee: Microbiology. Type: Traditional
Product code: SBF. Advisory committee: Neurology. Type: Special
Product code: FMK. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FMK. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Special
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: LPL. Advisory committee: Ophthalmic. Type: Special
Product code: HIF. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: QPC. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: MRD. Advisory committee: Unknown. Type: Traditional
Product code: PNG. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Special
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Special
Product code: KWQ. Advisory committee: Orthopedic. Type: Special
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: CEM. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: OXO. Advisory committee: Radiology. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: NRY. Advisory committee: Cardiovascular. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: SUBCUTANEOUS
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-306-02 (carton), NDC #: 49884-306-52 (blisters). — Reason: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. — Status: Ongoing
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05 — Reason: Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle — Status: Ongoing
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03 — Reason: Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles. — Status: Terminated