News about "ANDA approval"

Alembic Pharmaceuticals Announces US FDA Final Approval for Tretinoin Cream

Alembic Pharmaceuticals has received US Food and Drug Administration (FDA) final approval for Tretinoin Cream USP, 0.05 percent, a generic version of Bausch Health’s Retin-A Cream.

ANDA Approval | 12/06/2026 | By News Bureau

Alembic Pharma Receives USFDA Approval for Haloperidol Tablets

Alembic Pharmaceuticals has received final US FDA approval for Haloperidol Tablets USP in multiple strengths. The medication is indicated for the management of psychotic disorders and the treatment of tics and vocal utterances associated with Tourette’s Disorder in both children and adults, expanding Alembic’s US CNS product portfolio.

ANDA Approval | 05/06/2026 | By News Bureau

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.

ANDA Approval | 02/06/2026 | By News Bureau

Alembic Pharmaceuticals Receives US FDA Final Approval for Levothyroxine Sodium Tablets

Alembic Pharmaceuticals receives final US Food and Drug Administration (FDA) approval for multiple strengths of Levothyroxine Sodium Tablets USP, expanding its portfolio of generic therapies for thyroid disorder management.

ANDA Approval | 22/05/2026 | By News Bureau

Lupin Gets US FDA Tentative Approval for Revefenacin Inhalation Solution

Lupin receives tentative US Food and Drug Administration (FDA) approval for Revefenacin Inhalation Solution, a generic version of Yupelri for maintenance treatment of Chronic
Obstructive Pulmonary Disease (COPD).<br />

ANDA Approval | 20/05/2026 | By News Bureau

Alembic Pharmaceuticals Gets US FDA Tentative Nod for Darolutamide Tablets

Alembic Pharmaceuticals receives tentative US Food and Drug Administration (FDA) approval for Darolutamide Tablets 300 mg, a generic equivalent to Nubeqa by Bayer.

ANDA Approval | 15/05/2026 | By News Bureau

Lupin Secures FDA Approval for Famotidine Injection USP

Lupin has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Famotidine injection USP, 20 mg/2 mL (10 mg/mL), single-dose vials.

ANDA Approval | 14/05/2026 | By News Bureau |  121

Lupin Receives US FDA Approval for Glycerol Phenylbutyrate Oral Liquid

Lupin secures US Food and Drug Administration (FDA) approval for Glycerol Phenylbutyrate Oral Liquid (1.1 g/mL), bioequivalent to Ravicti Oral Liquid.

ANDA Approval | 05/05/2026 | By News Bureau

Alembic Pharmaceuticals Secures US FDA Nod for Fingolimod Capsules

Alembic Pharmaceuticals receives US FDA approval for fingolimod capsules, expanding access to a key multiple sclerosis treatment in the US market.

ANDA Approval | 27/04/2026 | By News Bureau |  103

Lupin Launches Diabetes Drug Combination in the US

Lupin launches dapagliflozin and metformin extended-release tablets in the US, offering a bioequivalent and cost-effective alternative for type 2 diabetes management.

ANDA Approval | 22/04/2026 | By News Bureau |  114