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19,683 catalysts · 4,728 grant · 3,126 8k filing · 2,785 device 510k · 2,724 approval · 2,000 device recall · 1,962 device pma
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19,683 catalysts · 4,728 grant · 3,126 8k filing · 2,785 device 510k · 2,724 approval · 2,000 device recall · 1,962 device pma
Supplement type: Normal 180 Day Track. Product code: LMF. Advisory committee: SU. Decision: APPR
Supplement type: Real-Time Process. Product code: QQK. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: NQA. Advisory committee: DE. Decision: APPR
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: FDS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: CCK. Advisory committee: Anesthesiology. Type: Traditional
Product code: QVP. Advisory committee: Microbiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: PEM. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: BTO. Advisory committee: Anesthesiology. Type: Traditional
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister) — Reason: CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. — Status: Ongoing
Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card). — Reason: cGMP deviations — Status: Ongoing
Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8 88277 34945 5 — Reason: Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol — Status: Ongoing
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30 — Reason: CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. — Status: Ongoing
Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4 — Reason: Defective Container: This recall is being initiated due to a leaking unit stored horizontally. — Status: Ongoing
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: MVC. Advisory committee: PA. Decision: APPR
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: PZK. Advisory committee: OP. Decision: APPR
Supplement type: 30-Day Notice. Product code: LXA. Advisory committee: CV. Decision: OK30
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HTY. Advisory committee: Orthopedic. Type: Traditional
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Traditional
Product code: BTR. Advisory committee: Anesthesiology. Type: Special
Product code: SAH. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FAJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HQC. Advisory committee: Ophthalmic. Type: Traditional
Product code: KIF. Advisory committee: Dental. Type: Traditional
Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: PHATHOM. Form: CAPSULE, TABLET, TABLET. Route: ORAL
Sponsor: PHATHOM. Form: CAPSULE, TABLET. Route: ORAL
Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL
Supplement type: Normal 180 Day Track No User Fee. Product code: NKE. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MRM. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: OVD. Advisory committee: Orthopedic. Type: Special
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Product code: FTL. Advisory committee: General, Plastic Surgery. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JDS. Advisory committee: Orthopedic. Type: Traditional