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22,269 catalysts · 4,728 grant · 4,138 device 510k · 3,621 8k filing · 3,132 approval · 2,000 device pma · 2,000 device recall
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22,269 catalysts · 4,728 grant · 4,138 device 510k · 3,621 8k filing · 3,132 approval · 2,000 device pma · 2,000 device recall
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
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: GWG. Advisory committee: Neurology. Type: Special
Product code: OMB. Advisory committee: Neurology. Type: Traditional
Product code: QQU. Advisory committee: Ophthalmic. Type: Traditional
Product code: FTL. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QBJ. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: OMB. Advisory committee: Neurology. Type: Traditional
Product code: SEC. Advisory committee: Physical Medicine. Type: Direct
Sponsor: ARGENX BV. Form: INJECTABLE. Route: INJECTION
Sponsor: ADIENNE SA. Form: POWDER. Route: INTRAVENOUS
Sponsor: RUBICON RESEARCH. Form: SOLUTION. Route: ORAL
Product code: OLZ. Advisory committee: Neurology. Type: Traditional
Product code: KWQ. Advisory committee: Orthopedic. Type: Special
Product code: OVE. Advisory committee: Orthopedic. Type: Traditional
Product code: MQL. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Product code: MQL. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Special
Product code: GXH. Advisory committee: Neurology. Type: Traditional
Product code: EBZ. Advisory committee: Dental. Type: Traditional
Product code: KNT. Advisory committee: Gastroenterology, Urology. Type: Traditional
Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION
Sponsor: INDIVIOR. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS
Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: VIIV HLTHCARE. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR
Product code: EBZ. Advisory committee: Dental. Type: Traditional
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