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23,207 catalysts · 4,956 device 510k · 4,728 grant · 3,543 approval · 3,189 8k filing · 2,000 device pma · 2,000 device recall
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23,207 catalysts · 4,956 device 510k · 4,728 grant · 3,543 approval · 3,189 8k filing · 2,000 device pma · 2,000 device recall
Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Product code: HSN. Advisory committee: Orthopedic. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: KPR. Advisory committee: Radiology. Type: Traditional
Product code: JKA. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: ONW. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GAG. Advisory committee: General Hospital. Type: Traditional
Product code: FED. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: HTN. Advisory committee: Orthopedic. Type: Traditional
Product code: EHD. Advisory committee: Dental. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OIY. Advisory committee: Orthopedic. Type: Traditional
Product code: DXF. Advisory committee: Cardiovascular. Type: Special
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: HQD. Advisory committee: Ophthalmic. Type: Traditional
Product code: KOB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: JWJ. Advisory committee: Orthopedic. Type: Special
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