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29 catalysts · 14 approval · 10 device 510k · 3 device pma · 2 grant
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29 catalysts · 14 approval · 10 device 510k · 3 device pma · 2 grant
Sponsor: TARO PHARM INDS. Form: TABLET. Route: ORAL
Sponsor: TARO PHARM INDS. Form: TABLET. Route: ORAL
Sponsor: HIKMA. Form: SYRUP. Route: ORAL
Sponsor: HIKMA. Form: SYRUP. Route: ORAL
Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: MARKSANS PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: INCYTE CORP. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: BAXTER HLTHCARE CORP. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Sponsor: FRESENIUS KABI USA. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: STERISCIENCE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: ESKAYEF. Form: CAPSULE. Route: ORAL
Sponsor: SUN PHARM INDS LTD. Form: CAPSULE. Route: ORAL
Sponsor: WATSON LABS TEVA. Form: TABLET. Route: ORAL
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Dual Track
Product code: EIH. Advisory committee: Dental. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Advisory committee: Unknown. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: SGA. Advisory committee: Immunology. Type: Special
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: MOL. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Supplement type: Real-Time Process. Product code: DXY. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: MMY. Advisory committee: GU. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: QQK. Advisory committee: GU. Decision: APPR
HL grant. $38,224. PI: Phinea Z Romero
AI grant. $50,114. PI: Tracy Biaco