News about "ANDA approval"

Alembic Pharmaceuticals Receives US FDA Approval for Dapsone Gel 5 Percent

Alembic Pharmaceuticals has received US FDA approval for Dapsone Gel 5 percent, a topical treatment for acne vulgaris.

ANDA Approval | 29/06/2026 | By News Bureau

Lupin Receives US FDA Tentative Approval for Enzalutamide Tablets

Lupin has received tentative US Food and Drug Administration (FDA) approval for Enzalutamide tablets in 40 mg, 80 mg, 120 mg, and 160 mg strengths.

ANDA Approval | 29/06/2026 | By News Bureau

Alembic Pharmaceuticals Announces US FDA Tentative Approval for Binimetinib Tablets, 45 mg

Alembic Pharmaceuticals has received the US Food and Drug Administration (FDA) tentative approval for Binimetinib Tablets 45 mg, a generic version of Mektovi (binimetinib).

ANDA Approval | 20/06/2026 | By News Bureau |  129

Alembic Pharma Receives US FDA Approval for Generic Tretinoin Cream

Alembic Pharmaceuticals has secured final USFDA approval for its generic Tretinoin Cream USP, 0.05 percent, used in the treatment of acne vulgaris, targeting a US market estimated at USD 76 million.

ANDA Approval | 16/06/2026 | By News Bureau |  110

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 |  104

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 |  311

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