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News about "Abbreviated New Drug Application (ANDA) "
Alembic Pharmaceuticals Receives USFDA Approval for Generic Dasatinib Tablets
Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dasatinib Tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.
Abbreviated New Drug Application (ANDA) | 07/11/2025 | By Dineshwori
Alembic Pharmaceuticals Secures USFDA Approval for Ticagrelor Tablets, 60 mg
Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ticagrelor Tablets, 60 mg. The product is therapeutically equivalent to Brilinta Tablets, 60 mg, from AstraZeneca.
Abbreviated New Drug Application (ANDA) | 29/10/2025 | By Dineshwori
Alembic Wins USFDA Clearance for Paroxetine ER Tablets for Depression and Anxiety Disorders
Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg.
Abbreviated New Drug Application (ANDA) | 25/09/2025 | By Dineshwori
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 | 167
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 | 186
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 | 166
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