USFDA9 Feb 2024, 06:47 pm
Zydus Lifesciences Receives Tentative Approval from USFDA for Dexamethasone Tablets
AI Summary
Zydus Lifesciences Limited has received tentative approval from the USFDA to manufacture and market Dexamethasone Tablets USP, 1 mg, with annual sales of USD 1.8 mn in the United States. This brings the company's total approvals to 387 and marks another successful filing under the ANDA process.,
Key Highlights
- Tentative approval from USFDA for Dexamethasone Tablets
- Annual sales of USD 1.8 mn in the United States
- 387 approvals and 460 ANDAs filed since FY 2003-04