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21,750 catalysts · 4,728 grant · 4,087 device 510k · 3,180 8k filing · 3,117 approval · 2,000 device pma · 2,000 device recall
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21,750 catalysts · 4,728 grant · 4,087 device 510k · 3,180 8k filing · 3,117 approval · 2,000 device pma · 2,000 device recall
Sponsor: AMNEAL. Form: CAPSULE. Route: ORAL
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: IYE. Advisory committee: Radiology. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: FET. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OVE. Advisory committee: Orthopedic. Type: Traditional
Product code: SAQ. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: EIA. Advisory committee: Dental. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Special
Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: QWH. Advisory committee: Clinical Chemistry. Type: Traditional
Sponsor: SANDOZ INC. Form: INJECTABLE. Route: INJECTION
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Product code: MQC. Advisory committee: Unknown. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Abbreviated
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: CJY. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional
Product code: KPI. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NFO. Advisory committee: Neurology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Sponsor: ACCORD. Form: EMULSION. Route: SUBCUTANEOUS
Sponsor: GENENTECH INC. Form: TABLET. Route: ORAL
Sponsor: GENENTECH INC. Form: FOR SOLUTION. Route: ORAL
Sponsor: RHODES PHARMS. Form: TABLET. Route: ORAL
Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: KCT. Advisory committee: General Hospital. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: QQX. Advisory committee: Microbiology. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: OVE. Advisory committee: Orthopedic. Type: Traditional
Product code: BTR. Advisory committee: Anesthesiology. Type: Traditional
Product code: QYT. Advisory committee: Microbiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: QRC. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KWT. Advisory committee: Orthopedic. Type: Traditional
Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION
Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION
Sponsor: ASTELLAS. Form: SOLUTION. Route: INTRAVITREAL
Sponsor: PFIZER. Form: TABLET. Route: ORAL
Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION
Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: SOMERSET THERAPS LLC. Form: SOLUTION. Route: INHALATION, ORAL
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00. — Reason: CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit. — Status: Terminated
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16 — Reason: Superpotent; sodium benzoate preservative — Status: Completed