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32 catalysts · 15 device pma · 13 device 510k · 4 approval
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32 catalysts · 15 device pma · 13 device 510k · 4 approval
Sponsor: JANSSEN PHARMS. Form: TABLET. Route: ORAL
Sponsor: JANSSEN PHARMS. Form: FOR SUSPENSION. Route: ORAL
Sponsor: MICRO LABS. Form: CAPSULE. Route: ORAL
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: LWO. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: PNJ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: QIT. Advisory committee: OP. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: OCM. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: NIK. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: NKE. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: DXY. Advisory committee: CV. Decision: APPR
Product code: EZW. Advisory committee: GU. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: LWS. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: LWP. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: OCM. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: QIT. Advisory committee: OP. Decision: OK30
Product code: QVL. Advisory committee: Orthopedic. Type: Direct
Product code: SCA. Advisory committee: Microbiology. Type: Dual Track
Product code: LZA. Advisory committee: General Hospital. Type: Traditional
Product code: DXH. Advisory committee: Cardiovascular. Type: Traditional
Product code: OWX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KDN. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: MUJ. Advisory committee: Radiology. Type: Traditional
Product code: MQB. Advisory committee: Radiology. Type: Traditional
Product code: SFD. Advisory committee: Neurology. Type: Direct
Product code: OAP. Advisory committee: Physical Medicine. Type: Traditional
Product code: IYO. Advisory committee: Radiology. Type: Traditional