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48 catalysts · 16 approval · 12 device 510k · 11 device pma · 9 grant
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48 catalysts · 16 approval · 12 device 510k · 11 device pma · 9 grant
Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION
Sponsor: COSETTE. Form: TABLET. Route: ORAL
Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL
Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL
Sponsor: YICHANG HUMANWELL. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: ORGANON USA LLC. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: AUROBINDO PHARMA LTD. Form: CAPSULE. Route: ORAL
Sponsor: BIOCON PHARMA. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: ARRAY BIOPHARMA INC. Form: CAPSULE. Route: ORAL
Sponsor: ARRAY BIOPHARMA INC. Form: CAPSULE. Route: ORAL
Sponsor: FOURRTS LABS. Form: CAPSULE. Route: ORAL
Sponsor: FOUGERA PHARMS. Form: OINTMENT. Route: TOPICAL
Sponsor: FOUGERA PHARMS. Form: OINTMENT. Route: TOPICAL
Sponsor: FOUGERA PHARMS. Form: OINTMENT. Route: TOPICAL
Sponsor: IPCA LABS LTD. Form: TABLET. Route: ORAL
Sponsor: ORBICULAR. Form: SOLUTION. Route: SUBCUTANEOUS
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Special
Product code: IYO. Advisory committee: Radiology. Type: Traditional
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Special
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MAI. Advisory committee: Orthopedic. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Product code: QJF. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JOW. Advisory committee: Cardiovascular. Type: Traditional
Supplement type: 30-Day Notice. Product code: MAQ. Advisory committee: MI. Decision: OK30
Supplement type: Real-Time Process. Product code: EZW. Advisory committee: GU. Decision: APPR
Supplement type: Real-Time Process. Product code: QON. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: MPW. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: NEK. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPZ. Advisory committee: DE. Decision: OK30
Supplement type: 30-Day Notice. Product code: SGV. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: NGV. Advisory committee: CV. Decision: OK30
AI grant. $427,623. PI: George Kyei
AI grant. $447,604. PI: VICTORIA L ROBINSON
DK grant. $797,878. PI: ROBERTO Ariel GOMEZ
GM grant. $422,677. PI: Valerie Cortez
NR grant. $472,950. PI: Christine March
GM grant. $401,285. PI: Dhiman Ray
ES grant. $415,613. PI: MATTHEW D RAND
AI grant. $624,521. PI: ADRIAN T TING
AI grant. $718,637. PI: Nadejda S Beliakova-Bethell