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9,257 catalysts · 3,126 8k filing · 2,029 grant · 1,000 device adverse event · 897 approval · 659 device 510k · 583 earnings
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9,257 catalysts · 3,126 8k filing · 2,029 grant · 1,000 device adverse event · 897 approval · 659 device 510k · 583 earnings
Sponsor: CHEPLAPHARM. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: SUNSHINE. Form: TABLET. Route: ORAL
Sponsor: SUNSHINE. Form: TABLET. Route: ORAL
Sponsor: CHEPLAPHARM. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR
Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION
Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL
Sponsor: EUGIA PHARMA. Form: INJECTABLE. Route: INJECTION
Sponsor: CIPLA LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: HIKMA PHARMS. Form: FOR SUSPENSION. Route: ORAL
Sponsor: PH HEALTH. Form: CAPSULE. Route: ORAL
Sponsor: GILEAD SCIENCES INC. Form: CAPSULE. Route: ORAL
Sponsor: EPIC PHARMA LLC. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: EPIC PHARMA LLC. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: EPIC PHARMA LLC. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: CHEPLAPHARM. Form: POWDER. Route: INTRAMUSCULAR
Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: ALKERMES INC. Form: TABLET. Route: ORAL
Sponsor: PLATINUM. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: BIONPHARMA. Form: CAPSULE. Route: ORAL
Sponsor: MEITHEAL. Form: POWDER. Route: INTRAVENOUS
Sponsor: NOVO. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: IMMUNEX. Form: SYRINGE
Sponsor: JUBILANT GENERICS. Form: TABLET. Route: ORAL
Product code: GQG. Advisory committee: Microbiology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Product code: EBW. Advisory committee: Dental. Type: Traditional
Product code: FDF. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KDN. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: POK. Advisory committee: Radiology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DWF. Advisory committee: Cardiovascular. Type: Traditional
Product code: SCL. Advisory committee: General Hospital. Type: Traditional
Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: NIU. Advisory committee: CV. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: ONU. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MNQ. Advisory committee: AN. Decision: OK30
Product code: SGU. Advisory committee: NE. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: PRC. Advisory committee: CV. Decision: APPR
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 — Reason: A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment — Status: Ongoing
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851 — Reason: The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older. — Status: Ongoing
DxC 700 AU, REF: B86444, B86446 — Reason: A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment. — Status: Ongoing