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23,587 catalysts · 5,000 device 510k · 4,728 grant · 3,778 approval · 3,290 8k filing · 2,000 device pma · 2,000 device recall
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23,587 catalysts · 5,000 device 510k · 4,728 grant · 3,778 approval · 3,290 8k filing · 2,000 device pma · 2,000 device recall
Sponsor: AMGEN INC. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS
Sponsor: AMGEN INC. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS
Product code: PNP. Advisory committee: Dental. Type: Traditional
Product code: JDR. Advisory committee: Orthopedic. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: PBX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ONB. Advisory committee: General Hospital. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GXH. Advisory committee: Neurology. Type: Special
Sponsor: BRISTOL-MYERS SQUIBB. Form: INJECTABLE. Route: SUBCUTANEOUS
Product code: ELW. Advisory committee: Dental. Type: Abbreviated
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: QZL. Advisory committee: Radiology. Type: Special
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: OXO. Advisory committee: Radiology. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: HAW. Advisory committee: Neurology. Type: Traditional
Product code: OUR. Advisory committee: Orthopedic. Type: Special
Product code: PZZ. Advisory committee: Pathology. Type: Traditional
Sponsor: KADMON PHARMS LLC. Form: TABLET. Route: ORAL
Product code: QPB. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: CBK. Advisory committee: Anesthesiology. Type: Traditional
Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL
Sponsor: SCIEGEN PHARMS. Form: TABLET. Route: ORAL
Sponsor: SCIEGEN PHARMS. Form: TABLET. Route: ORAL
Sponsor: SCIEGEN PHARMS. Form: TABLET. Route: ORAL
Sponsor: SCIEGEN PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: SCIEGEN PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: SCIEGEN PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: LAURUS. Form: TABLET. Route: ORAL
Sponsor: LAURUS. Form: CAPSULE. Route: ORAL
Product code: BTA. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Special
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: BZD. Advisory committee: Anesthesiology. Type: Special
Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional
Product code: BZH. Advisory committee: Anesthesiology. Type: Traditional
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) 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
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01 — Reason: CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit. — Status: Ongoing
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate - 1 mg; Stannous Chloride Dihydrate - 0.D75 mg; L-Cysteine Hydrochloride Monohydrate - 1 mg; Sodium Citrate Dihydrate - 2.6 mg; Mannitol - 20 mg. The pH is adjusted to 5.6 to 5.7 with HCI or NaOH prior to lyophilization. Sealed under nitrogen. 30 Radioassay Information Labels with radiation warning symbol. 1 package insert, Rx only, Manufacture by: Curium US LLC, Maryland Heights, MO 63043, 69945-092-40 — Reason: Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product — Status: Terminated
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. — Status: Ongoing
Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. — Status: Ongoing
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA — Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit. — Status: Ongoing
Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. — Status: Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01 — Reason: CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit. — Status: Ongoing
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90 — Reason: CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit — Status: Terminated