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21,257 catalysts · 4,728 grant · 3,704 device 510k · 3,230 8k filing · 3,015 approval · 2,000 device pma · 2,000 device recall
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21,257 catalysts · 4,728 grant · 3,704 device 510k · 3,230 8k filing · 3,015 approval · 2,000 device pma · 2,000 device recall
Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-405-99 — Reason: cGMP deviations — Status: Terminated
Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00 — Reason: CGMP Deviations — Status: Ongoing
Product code: DWJ. Advisory committee: Cardiovascular. Type: Traditional
Product code: DYB. Advisory committee: Cardiovascular. Type: Special
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: JKA. Advisory committee: Clinical Chemistry. Type: Special
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: HKI. Advisory committee: Ophthalmic. Type: Traditional
Product code: OVD. Advisory committee: Orthopedic. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: NRY. Advisory committee: Cardiovascular. Type: Special
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: JPA. Advisory committee: Hematology. Type: Special
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Sponsor: ABBVIE. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL
Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ABBVIE. Form: TABLET, DELAYED RELEASE. Route: ORAL
Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Product code: FDS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Special
Product code: KCT. Advisory committee: General Hospital. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Special
Product code: HSN. Advisory committee: Orthopedic. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Special
Product code: KDN. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: MEH. Advisory committee: Orthopedic. Type: Traditional
Product code: DXF. Advisory committee: Cardiovascular. Type: Special
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Product code: FPA. Advisory committee: General Hospital. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional
Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: DSA. Advisory committee: Cardiovascular. Type: Special
Product code: CHL. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: JOJ. Advisory committee: General Hospital. Type: Special
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: DSH. Advisory committee: Cardiovascular. Type: Traditional
Product code: POV. Advisory committee: Hematology. Type: Dual Track
Product code: GZI. Advisory committee: Neurology. Type: Traditional
Product code: FOZ. Advisory committee: General Hospital. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: FBO. Advisory committee: Gastroenterology, Urology. Type: Traditional