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83 catalysts · 24 approval · 24 device 510k · 20 device recall · 15 device pma
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83 catalysts · 24 approval · 24 device 510k · 20 device recall · 15 device pma
Sponsor: ARS PHARMS OPERATION. Form: SPRAY. Route: NASAL
Sponsor: MERCK SHARP DOHME. Form: INJECTABLE. Route: INJECTION
Sponsor: SUN PHARM INDUSTRIES. Form: TABLET. Route: ORAL
Sponsor: CHARTWELL. Form: TABLET. Route: ORAL
Sponsor: AMNEAL PHARMS. Form: TABLET. Route: ORAL
Sponsor: CHARTWELL. Form: TABLET. Route: ORAL
Sponsor: HIKMA. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL
Sponsor: EUGIA PHARMA. Form: TABLET. Route: ORAL
Sponsor: HERITAGE. Form: TABLET. Route: ORAL
Sponsor: BOEHRINGER INGELHEIM. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: BAYER HLTHCARE. Form: CAPSULE. Route: ORAL
Sponsor: SYNDAX. Form: TABLET. Route: ORAL
Sponsor: SECURA. Form: CAPSULE. Route: ORAL
Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL
Sponsor: HIKMA PHARMS. Form: TABLET. Route: ORAL
Sponsor: SANDOZ. Form: TABLET. Route: ORAL
Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL
Sponsor: BOEHRINGER INGELHEIM. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: B BRAUN MEDICAL. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL
Sponsor: AMPHASTAR PHARMS INC. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: MSN. Form: TABLET. Route: ORAL
Sponsor: HIKMA. Form: TABLET. Route: ORAL
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Special
Product code: DQK. Advisory committee: Cardiovascular. Type: Abbreviated
Product code: QEZ. Advisory committee: Cardiovascular. Type: Traditional
Product code: FCG. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MUH. Advisory committee: Dental. Type: Traditional
Product code: DWJ. Advisory committee: Cardiovascular. Type: Traditional
Product code: MBH. Advisory committee: Orthopedic. Type: Traditional
Product code: CFR. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Special
Product code: LHI. Advisory committee: General Hospital. Type: Traditional
Product code: PHL. Advisory committee: Physical Medicine. Type: Traditional
Product code: FTL. Advisory committee: General, Plastic Surgery. Type: Special
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: IRP. Advisory committee: Physical Medicine. Type: Special
Product code: IZL. Advisory committee: Radiology. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Traditional
Product code: DWF. Advisory committee: Cardiovascular. Type: Special
Product code: GJS. Advisory committee: Hematology. Type: Special
Product code: NKG. Advisory committee: Orthopedic. Type: Special
Product code: QJP. Advisory committee: Cardiovascular. Type: Special
Product code: IYE. Advisory committee: Radiology. Type: Traditional
Supplement type: Real-Time Process. Product code: NIK. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30