Regulatorische Updates
23. Sept. 2026•1 Min. Lesezeit
FDA Approves Multiple Supplemental Applications for LIDOPEN (NDA 017549)
The FDA has granted approval for several supplemental submissions related to LIDOPEN, an injectable lidocaine product now discontinued.
Regulatorische Updates
15. Sept. 2026•1 Min. Lesezeit
FDA Approves Multiple Labeling Supplements for MirtaZAPINE (ANDA 076901)
FDA's ANDA 076901 for MirtaZAPINE includes three discontinued oral tablet strengths and a series of approved labeling supplements dating from 2005 to 2025.
Regulatorische Updates
10. Sept. 2026•1 Min. Lesezeit
FDA NDA 007883: Antabuse (disulfiram) supplemental manufacturing and labeling submissions
The FDA NDA 007883 for Antabuse lists two discontinued tablet strengths and a series of priority supplemental submissions for manufacturing and labeling, all approved.
Regulatorische Updates
5. Sept. 2026•1 Min. Lesezeit
Quinapril Hydrochloride and Hydrochlorothiazide Tablets – FDA Labeling Approvals (ANDA 077093)
FDA records show labeling approvals for discontinued quinapril/hydrochlorothiazide tablets across multiple supplemental applications from 2011 to 2022.
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
FDA Approves Supplemental ANDA 086178 for GLYCOPYRROLATE Tablet
FDA records approval of a supplemental manufacturing (CMC) submission for ANDA 086178, covering the oral GLYCOPYRROLATE 2 mg tablet by Watson Labs, now listed as discontinued.