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21,823 catalysts · 4,728 grant · 4,110 device 510k · 3,229 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall
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21,823 catalysts · 4,728 grant · 4,110 device 510k · 3,229 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall
Product code: BTL. Advisory committee: Anesthesiology. Type: Traditional
Product code: MUJ. Advisory committee: Radiology. Type: Traditional
Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: QDA. Advisory committee: Cardiovascular. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Special
Product code: KPO. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NBL. Advisory committee: Dental. Type: Traditional
Product code: QEA. Advisory committee: Neurology. Type: Traditional
Product code: QHA. Advisory committee: Radiology. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Special
Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL
Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL
Sponsor: NOVARTIS. Form: TABLET. Route: ORAL
Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL
Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION
Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION
Sponsor: AMGEN INC. Form: INJECTABLE. Route: INJECTION
Sponsor: CELLTRION. Form: INJECTABLE. Route: INJECTION
Product code: ORQ. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QAI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FTC. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Traditional
Product code: PHZ. Advisory committee: Anesthesiology. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION
Sponsor: UCB INC. Form: SOLUTION. Route: ORAL
Product code: KGI. Advisory committee: Radiology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Special
Product code: QLY. Advisory committee: General Hospital. Type: Traditional
Product code: OKO. Advisory committee: General, Plastic Surgery. Type: Special
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Special
Product code: GYB. Advisory committee: Neurology. Type: Traditional
Product code: NXC. Advisory committee: Dental. Type: Special
Product code: MOL. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: OMT. Advisory committee: General, Plastic Surgery. Type: Traditional
Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13 — Reason: Failed dissolution specifications: lower than specifications — Status: Ongoing
Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04. — Reason: Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution. — Status: Terminated
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05. — Reason: Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim. — Status: Ongoing
Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-294-21, Unit Dose NDC 60687-294-11. — Reason: cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product. — Status: Terminated
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10. — Reason: CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit. — Status: Ongoing
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01 — Reason: CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit. — Status: Ongoing
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: SEF. Advisory committee: General Hospital. Type: Traditional
Product code: BZQ. Advisory committee: Anesthesiology. Type: Traditional