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22,546 catalysts · 4,728 grant · 4,492 device 510k · 3,350 8k filing · 3,218 approval · 2,000 device pma · 2,000 device recall
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22,546 catalysts · 4,728 grant · 4,492 device 510k · 3,350 8k filing · 3,218 approval · 2,000 device pma · 2,000 device recall
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. — Reason: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. — Status: Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. — Status: Ongoing
Product code: PKL. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: LBH. Advisory committee: Dental. Type: Traditional
Product code: GXY. Advisory committee: Neurology. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Special
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Sponsor: AGIOS PHARMS INC. Form: TABLET. Route: ORAL
Product code: FDF. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DZL. Advisory committee: Dental. Type: Traditional
Product code: KPR. Advisory committee: Radiology. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: MMI. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: GWN. Advisory committee: Neurology. Type: Traditional
Product code: MRN. Advisory committee: Anesthesiology. Type: Special
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: OLR. Advisory committee: Unknown. Type: Traditional
Product code: DYH. Advisory committee: Dental. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: KPR. Advisory committee: Radiology. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: JAA. Advisory committee: Radiology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: KGN. Advisory committee: Unknown. Type: Traditional
Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE. Route: ORAL
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: KPR. Advisory committee: Radiology. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional
Product code: PTA. Advisory committee: Immunology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Sponsor: ZYDUS PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15. — Reason: LABELING: LABEL MIX-UP — Status: Ongoing
Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack — Reason: Crystallization — Status: Ongoing
Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15. — Reason: Failed Dissolution Specifications — Status: Ongoing
Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-03 — Reason: Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study. — Status: Terminated