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21,677 catalysts · 4,728 grant · 4,071 device 510k · 3,126 8k filing · 3,114 approval · 2,000 device pma · 2,000 device recall
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21,677 catalysts · 4,728 grant · 4,071 device 510k · 3,126 8k filing · 3,114 approval · 2,000 device pma · 2,000 device recall
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73. — Reason: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules — Status: Ongoing
Product code: OLP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HAW. Advisory committee: Neurology. Type: Traditional
Product code: IPF. Advisory committee: Physical Medicine. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: MAI. Advisory committee: Orthopedic. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: FMF. Advisory committee: General Hospital. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Sponsor: KINDOS. Form: INJECTABLE. Route: INJECTION
Product code: FRC. Advisory committee: General Hospital. Type: Special
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: FTC. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FRC. Advisory committee: General Hospital. Type: Special
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ISA. Advisory committee: Physical Medicine. Type: Traditional
Product code: GXY. Advisory committee: Neurology. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Special
Product code: PKL. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Special
Product code: NGL. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: DQX. Advisory committee: Cardiovascular. Type: Special
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS
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