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19,717 catalysts · 4,728 grant · 3,187 8k filing · 2,768 device 510k · 2,721 approval · 2,000 device recall · 1,955 device pma
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19,717 catalysts · 4,728 grant · 3,187 8k filing · 2,768 device 510k · 2,721 approval · 2,000 device recall · 1,955 device pma
Product code: CAF. Advisory committee: Anesthesiology. Type: Traditional
Product code: DWF. Advisory committee: Cardiovascular. Type: Traditional
Product code: LFX. Advisory committee: Microbiology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: MSW. Advisory committee: Immunology. Type: Traditional
Product code: HSN. Advisory committee: Orthopedic. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: UNIQUE PHARM. Form: TABLET. Route: ORAL
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION
Supplement type: Normal 180 Day Track. Product code: PYX. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: NIM. Advisory committee: CV. Decision: APPR
Product code: NIM. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: QRH. Advisory committee: GU. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: OZD. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30
Product code: EBG. Advisory committee: Dental. Type: Traditional
Product code: KOI. Advisory committee: Anesthesiology. Type: Traditional
Product code: SCW. Advisory committee: Ophthalmic. Type: Traditional
Product code: IQC. Advisory committee: Physical Medicine. Type: Traditional
Product code: NQQ. Advisory committee: Radiology. Type: Traditional
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: JTN. Advisory committee: Microbiology. Type: Traditional
Product code: IYE. Advisory committee: Radiology. Type: Traditional
Product code: FLL. Advisory committee: General Hospital. Type: Traditional
Sponsor: APOTEX INC. Form: TABLET. Route: ORAL
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL
Sponsor: KAMAT. Form: SOLUTION. Route: ORAL
Supplement type: 30-Day Notice. Product code: MRA. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: NRA. Advisory committee: OR. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: QCA. Advisory committee: NE. Decision: APPR
Product code: FMF. Advisory committee: General Hospital. Type: Special
Product code: OVD. Advisory committee: Orthopedic. Type: Special
Product code: MJN. Advisory committee: Cardiovascular. Type: Traditional
Product code: SFE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: HTY. Advisory committee: Orthopedic. Type: Traditional
Product code: KFM. Advisory committee: Cardiovascular. Type: Traditional
Sponsor: HIKMA. Form: TABLET. Route: ORAL
UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295 — Reason: Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole. — Status: Completed
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10 — Reason: cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). — Status: Ongoing
Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-401-25 — Reason: Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis. — Status: Ongoing
UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134 — Reason: Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac. — Status: Completed
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: NHL. Advisory committee: NE. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: Real-Time Process. Product code: MOM. Advisory committee: CV. Decision: APPR