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20,113 catalysts · 18,987 approval · 7,208 phase readout · 5,000 device 510k · 4,728 grant · 3,603 8k filing · 2,000 device pma
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20,113 catalysts · 18,987 approval · 7,208 phase readout · 5,000 device 510k · 4,728 grant · 3,603 8k filing · 2,000 device pma
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Sponsor: BAYER HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: FOR SUSPENSION. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: SCIEGEN PHARMS. Form: TABLET. Route: ORAL
Sponsor: NATCO. Form: TABLET. Route: ORAL
Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL
Sponsor: PRINSTON INC. Form: TABLET. Route: ORAL
Sponsor: PRINSTON INC. Form: TABLET. Route: ORAL
Sponsor: PRINSTON INC. Form: TABLET. Route: ORAL
Sponsor: PRINSTON INC. Form: TABLET. Route: ORAL
Sponsor: NAVINTA LLC. Form: TABLET. Route: ORAL
Sponsor: TAGI. Form: INJECTABLE. Route: INJECTION
Sponsor: MICRO LABS. Form: CAPSULE. Route: ORAL
Sponsor: SIGMAPHARM LABS LLC. Form: TABLET. Route: ORAL
Sponsor: INDUSTRIAL WELDING SUPPLY CO OF HARVEY INC. Form: GAS. Route: INHALATION
Sponsor: ACS DOBFAR. Form: INJECTABLE. Route: INJECTION
Sponsor: ACS DOBFAR. Form: INJECTABLE. Route: INJECTION
Sponsor: ACS DOBFAR. Form: INJECTABLE. Route: INJECTION
Sponsor: ACS DOBFAR. Form: INJECTABLE. Route: INJECTION
Sponsor: ACS DOBFAR. Form: INJECTABLE. Route: INJECTION
Sponsor: ACS DOBFAR. Form: INJECTABLE. Route: INJECTION
Sponsor: ACS DOBFAR. Form: INJECTABLE. Route: INJECTION
Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: ALEMBIC. Form: GEL. Route: TOPICAL
Sponsor: ALEMBIC. Form: GEL. Route: TOPICAL
Sponsor: SCIEGEN PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: WATSON LABS. Form: CAPSULE. Route: ORAL
Sponsor: GRAVITI PHARMS. Form: TABLET. Route: ORAL
Sponsor: QILU. Form: INJECTABLE. Route: INJECTION
Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: SCIENTURE. Form: SUSPENSION. Route: ORAL
Sponsor: CHARTWELL RX. Form: CAPSULE. Route: ORAL
Sponsor: CHARTWELL RX. Form: CAPSULE. Route: ORAL
Sponsor: AUROBINDO PHARMA. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: RIDGEBACK BIOTHERAPEUTICS. Form: POWDER. Route: IV (INFUSION)
Sponsor: IPCA LABS LTD. Form: CAPSULE. Route: ORAL
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63 — Reason: Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment. — Status: Ongoing
Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-111-11 — Reason: cGMP deviations — Status: Ongoing
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56. — Reason: Lack of Assurance of Sterility — Status: Ongoing
ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-354-01; Blister NDC 68084-354-11 — Reason: Defective container: Multiple customer complaints received for card seal defects observed on the subject lots. Customers reported card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities. — Status: Ongoing
Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing