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24,122 catalysts · 5,000 device 510k · 4,728 grant · 4,180 approval · 3,423 8k filing · 2,000 device pma · 2,000 device recall
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24,122 catalysts · 5,000 device 510k · 4,728 grant · 4,180 approval · 3,423 8k filing · 2,000 device pma · 2,000 device recall
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15. — 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
Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10), 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, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (NDC 0378-1800-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. — Reason: Superpotent Drug and Subpotent Drug: potency failures obtained — Status: Ongoing
Product code: NQX. Advisory committee: Microbiology. Type: Special
Product code: MBH. Advisory committee: Orthopedic. Type: Special
Product code: MQL. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: MQL. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: LIT. Advisory committee: Cardiovascular. Type: Traditional
Product code: KCT. Advisory committee: General Hospital. Type: Traditional
Product code: BYI. Advisory committee: Anesthesiology. Type: Traditional
Product code: JOP. Advisory committee: Cardiovascular. Type: Traditional
Product code: MNR. Advisory committee: Anesthesiology. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: MBB. Advisory committee: Orthopedic. Type: Traditional
Product code: FAJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Traditional
Product code: ILX. Advisory committee: Physical Medicine. Type: Traditional
Product code: FPA. Advisory committee: General Hospital. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Special
Product code: EWL. Advisory committee: Ear, Nose, Throat. Type: Traditional
Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: ALKEM. Form: CAPSULE. Route: ORAL
Sponsor: GENZYME. Form: INJECTABLE. Route: INJECTION
Sponsor: SANDOZ. Form: CAPSULE. Route: ORAL
Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: INTRAVENOUS
Product code: PNR. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: FEB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FPD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: MQB. Advisory committee: Radiology. Type: Traditional
Product code: KGN. Advisory committee: Unknown. Type: Traditional
Product code: NXC. Advisory committee: Dental. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Special
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: PQA. Advisory committee: Microbiology. Type: Special
Product code: QDQ. Advisory committee: Radiology. Type: Special
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: FTC. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: BYI. Advisory committee: Anesthesiology. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: NFO. Advisory committee: Neurology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional