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20,538 catalysts · 4,728 grant · 3,336 device 510k · 3,126 8k filing · 2,847 approval · 2,000 device pma · 2,000 device recall
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20,538 catalysts · 4,728 grant · 3,336 device 510k · 3,126 8k filing · 2,847 approval · 2,000 device pma · 2,000 device recall
Product code: MSY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MUJ. Advisory committee: Radiology. Type: Traditional
Product code: HIF. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: FED. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FET. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NDN. Advisory committee: Orthopedic. Type: Traditional
Product code: QPF. Advisory committee: Neurology. Type: Traditional
Product code: EBW. Advisory committee: Dental. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: NQQ. Advisory committee: Radiology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Special
Product code: HHW. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Special
Product code: EBI. Advisory committee: Dental. Type: Abbreviated
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QQE. Advisory committee: Radiology. Type: Traditional
Product code: SEE. Advisory committee: Neurology. Type: Direct
Product code: MYN. Advisory committee: Radiology. Type: Traditional
Product code: QWR. Advisory committee: Microbiology. Type: Dual Track
Product code: JDR. Advisory committee: Orthopedic. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION
Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL
Product code: DPW. Advisory committee: Cardiovascular. Type: Traditional
Product code: EBF. Advisory committee: Dental. Type: Special
Product code: GYC. Advisory committee: Neurology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: ONG. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MLR. Advisory committee: General Hospital. Type: Traditional
Sponsor: RECORDATI RARE. Form: TABLET. Route: ORAL
Sponsor: SUNSHINE. Form: TABLET. Route: ORAL
Product code: PBX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: ORZ. Advisory committee: Ophthalmic. Type: Traditional
Product code: FAD. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: NGL. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: NPL. Advisory committee: Dental. Type: Special
Product code: PMU. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41 — Reason: Lack of Assurance of Sterility: Media fill with bacterial contamination — Status: Ongoing
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35 — Reason: CGMP Deviations — Status: Ongoing
Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua Therapeutics LLC an affiliate of Gilead Sciences, Inc., Foster City, CA 94404, Made in Ireland, NDC# 72626-2701-1 — Reason: Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton. — Status: Ongoing
Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-320-60 — Reason: CGMP Deviations — Status: Ongoing
Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India — Reason: CGMP Deviations — Status: Ongoing