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22,353 catalysts · 4,728 grant · 4,406 device 510k · 3,288 8k filing · 3,188 approval · 2,000 device pma · 2,000 device recall
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22,353 catalysts · 4,728 grant · 4,406 device 510k · 3,288 8k filing · 3,188 approval · 2,000 device pma · 2,000 device recall
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OVD. Advisory committee: Orthopedic. Type: Special
Product code: JAF. Advisory committee: Radiology. Type: Traditional
Product code: PZO. Advisory committee: Radiology. Type: Traditional
Sponsor: PFIZER. Form: INJECTABLE. Route: SUBCUTANEOUS
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional
Product code: IZL. Advisory committee: Radiology. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: NJD. Advisory committee: Orthopedic. Type: Traditional
Product code: KRD. Advisory committee: Cardiovascular. Type: Traditional
Product code: CCK. Advisory committee: Anesthesiology. Type: Traditional
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LQR. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: JXG. Advisory committee: Neurology. Type: Traditional
Sponsor: ALKEM LABS LTD. Form: TABLET. Route: ORAL
Sponsor: AMNEAL PHARMS. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: CELLTRION, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION
Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional
Product code: FGE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Abbreviated
Product code: DPS. Advisory committee: Cardiovascular. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: NGL. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: HKI. Advisory committee: Ophthalmic. Type: Traditional
Product code: MID. Advisory committee: Immunology. Type: Traditional
Product code: JOJ. Advisory committee: General Hospital. Type: Traditional
Product code: KGN. Advisory committee: Unknown. Type: Traditional
Product code: PSY. Advisory committee: Pathology. Type: Special
Product code: EBI. Advisory committee: Dental. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HHW. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: QLQ. Advisory committee: Orthopedic. Type: Traditional
Sponsor: XCOVERY. Form: CAPSULE. Route: ORAL
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL
Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL
Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. — Reason: Superpotent Drug and Subpotent Drug: potency failures obtained — Status: Ongoing
Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. — Reason: Superpotent Drug and Subpotent Drug: potency failures obtained — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-443-20 — Reason: Subpotent and Superpotent Drug — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-040-20 — Reason: Subpotent and Superpotent Drug — Status: Ongoing
Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. — Reason: Superpotent Drug and Subpotent Drug: potency failures obtained — Status: Ongoing