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13,326 catalysts · 3,350 8k filing · 2,401 grant · 2,076 approval · 1,436 device 510k · 1,072 device recall · 1,000 device adverse event
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13,326 catalysts · 3,350 8k filing · 2,401 grant · 2,076 approval · 1,436 device 510k · 1,072 device recall · 1,000 device adverse event
Supplement type: Real-Time Process. Product code: DSQ. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: LMG. Advisory committee: SU. Decision: APPR
Supplement type: Real-Time Process. Advisory committee: NE. Decision: APPR
Cardiosave Rescue. Intra-Aortic Balloon Pump system. — Reason: The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. — Status: Ongoing
Cardiosave Hybrid. Intra-Aortic Balloon Pump system. — Reason: The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. — Status: Ongoing
Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: NATCO PHARMA LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: AMNEAL PHARMS CO. Form: TABLET. Route: ORAL
Sponsor: PH HEALTH. Form: TABLET. Route: ORAL
Sponsor: ACTELION. Form: TABLET. Route: ORAL
Sponsor: NATCO PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: ACTELION. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: BAXTER HLTHCARE. Form: INJECTABLE. Route: INJECTION
Sponsor: B BRAUN. Form: INJECTABLE. Route: INJECTION
Sponsor: CADILA PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: BAXTER HLTHCARE. Form: INJECTABLE. Route: INJECTION
Sponsor: B BRAUN. Form: INJECTABLE. Route: INJECTION
Sponsor: BAUSCH. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: NALPROPION. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: NALPROPION. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: LAURUS. Form: TABLET. Route: ORAL
Sponsor: BAXTER HLTHCARE. Form: INJECTABLE. Route: INJECTION
Sponsor: IMPAX LABS. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: GLAXOSMITHKLINE. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: RISING. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ASCENT PHARMS INC. Form: SOLUTION. Route: ORAL
Sponsor: INTRA-CELLULAR. Form: CAPSULE. Route: ORAL
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: AXSOME. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: TWI PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: UMEDICA. Form: TABLET, DELAYED RELEASE. Route: ORAL
Sponsor: JUBILANT GENERICS. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: BAUSCH. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: AUROBINDO PHARMA USA. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA USA. Form: TABLET. Route: ORAL
Sponsor: MICRO LABS. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL
Sponsor: B BRAUN. Form: INJECTABLE. Route: INJECTION
Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01 — Reason: CGMP Deviations: Potential presence of metal particulate matter — Status: Ongoing
Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10 — Reason: CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. — Status: Ongoing
Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-051-88. — Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. — Status: Ongoing
Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10 — Reason: CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. — Status: Ongoing
Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0387-01 — Reason: CGMP Deviations: Potential presence of metal particulate matter — Status: Ongoing