News about "Abbreviated New Drug Application (ANDA) "

Lupin Receives US FDA Approval for Sodium Sulfate, Magnesium Sulfate and Potassium Chloride Tablets

Lupin has received US FDA approval for its Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, a bioequivalent to Reference Listed Drug (RLD) Sutab Tablets of Azurity Pharmaceuticals.

Abbreviated New Drug Application (ANDA) | 02/06/2026 | By News Bureau

Lupin Gets US FDA Tentative Approval for Pitolisant Tablets

US FDA grants tentative approval to Lupin’s Pitolisant Tablets (4.45 mg, 17.8 mg), bioequivalent to Wakix, for approved indications.

Abbreviated New Drug Application (ANDA) | 25/03/2026 | By News Bureau |  117

Biocon Receives US FDA Approval for Everolimus Tablets for Oral Suspension

Biocon has secured US FDA approval for Everolimus Tablets for Oral Suspension, enhancing its portfolio of vertically integrated drug products and expanding treatment options for patients in key markets.

Abbreviated New Drug Application (ANDA) | 13/01/2026 | By News Bureau |  172

Granules Pharmaceuticals Secures US FDA Tentative Approval for gDYANAVEL XR

The tentative approval clears a key regulatory milestone for Granules Pharmaceuticals’ Abbreviated New Drug Application (ANDA), which the US FDA has determined to be eligible for 180-day market exclusivity.

Abbreviated New Drug Application (ANDA) | 09/01/2026 | By News Bureau |  166

Alembic Pharma Wins USFDA Approval for Travoprost Ophthalmic Solution

Alembic Pharmaceuticals has secured USFDA approval for its Travoprost Ophthalmic Solution, with the ANDA deemed therapeutically equivalent to the reference listed drug Travatan Z (0.004%) from Sandoz.

Abbreviated New Drug Application (ANDA) | 18/12/2025 | By News Bureau |  138

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 |  511

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 |  308

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 |  182

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 |  345

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 |  438