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23,450 catalysts · 5,000 device 510k · 4,728 grant · 3,778 approval · 3,153 8k filing · 2,000 device pma · 2,000 device recall
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23,450 catalysts · 5,000 device 510k · 4,728 grant · 3,778 approval · 3,153 8k filing · 2,000 device pma · 2,000 device recall
Product code: OAP. Advisory committee: Physical Medicine. Type: Traditional
Product code: DRF. Advisory committee: Cardiovascular. Type: Traditional
Product code: KTT. Advisory committee: Orthopedic. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KLE. Advisory committee: Dental. Type: Traditional
Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL
Product code: NBW. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: SDE. Advisory committee: Ophthalmic. Type: Direct
Product code: ORZ. Advisory committee: Ophthalmic. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: DYB. Advisory committee: Cardiovascular. Type: Special
Product code: FRG. Advisory committee: General Hospital. Type: Traditional
Sponsor: UPSHER SMITH LABS. Form: TABLET. Route: ORAL
Product code: KWQ. Advisory committee: Orthopedic. Type: Traditional
Product code: MEB. Advisory committee: General Hospital. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: GWF. Advisory committee: Neurology. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: IZQ. Advisory committee: Cardiovascular. Type: Traditional
Product code: FMK. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MCW. Advisory committee: Cardiovascular. Type: Special
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24 — Reason: Superpotent Drug: Stability failure for assay at 6 months test time-point. — Status: Terminated
Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA. — Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. — Status: Ongoing
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30. — Reason: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit — Status: Ongoing
Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA. — Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. — Status: Ongoing
Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30. — Reason: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit — Status: Ongoing
Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA. — Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. — Status: Ongoing
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30. — Reason: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit — Status: Ongoing
Product code: PCC. Advisory committee: Neurology. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Traditional
Product code: QDS. Advisory committee: Pathology. Type: Special
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: MBH. Advisory committee: Orthopedic. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DQX. Advisory committee: Cardiovascular. Type: Traditional
Sponsor: AZURITY. Form: TABLET. Route: ORAL
Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL
Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL
Product code: CCK. Advisory committee: Anesthesiology. Type: Traditional
Product code: NEU. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KIF. Advisory committee: Dental. Type: Traditional
Product code: QSM. Advisory committee: Gastroenterology, Urology. Type: Traditional