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20,340 catalysts · 4,728 grant · 3,189 8k filing · 3,175 device 510k · 2,805 approval · 2,000 device pma · 2,000 device recall
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20,340 catalysts · 4,728 grant · 3,189 8k filing · 3,175 device 510k · 2,805 approval · 2,000 device pma · 2,000 device recall
Product code: EZL. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: FDS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QVF. Advisory committee: Microbiology. Type: Dual Track
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
Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION
Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL
Sponsor: ACTAVIS LABS FL. Form: CAPSULE. Route: ORAL
Sponsor: IMMUNEX. Form: SYRINGE
Sponsor: AVYXA HOLDINGS. Form: POWDER. Route: INTRAVENOUS
Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7. — Reason: Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents. — Status: Ongoing
Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15 — Reason: Failed Dissolution Specifications — Status: Ongoing
ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J. — Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil. — Status: Ongoing
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68 — Reason: Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct. — Status: Ongoing
Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71 — Reason: Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule — Status: Ongoing