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News about "Abbreviated New Drug Application (ANDA) "
Lupin Secures US FDA Approval for Lenalidomide Capsules
The approved Lenalidomide Capsules, bioequivalent to Revlimid by Bristol-Myers Squibb, will be produced at Lupin’s Pithampur site in India.
Abbreviated New Drug Application (ANDA) | 17/09/2025 | By Dineshwori
Alembic Pharma Receives USFDA Final Approval for Macitentan Tablets, 10 mg
Alembic Pharmaceuticals Ltd. has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Macitentan Tablets, 10 mg.
Abbreviated New Drug Application (ANDA) | 20/08/2025 | By Dineshwori
Amphastar Secures FDA Approval for Generic Iron Sucrose Injection
The US FDA has approved Amphastar's Abbreviated New Drug Application (ANDA) for iron sucrose injection, an iron replacement product indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease.
Abbreviated New Drug Application (ANDA) | 12/08/2025 | By Dineshwori
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