News about "ANDA approval"

Lupin Secures US Approval for Sodium Zirconium Cyclosilicate Oral Suspension

Lupin has received US Food and Drug Administration (FDA) approval for Sodium Zirconium Cyclosilicate Oral Suspension, 5 g and 10 g, bioequivalent to AstraZeneca’s Lokelma.

ANDA Approval | 11/08/2026 | By News Bureau

Zydus Wins US FDA Approval for Generic Indocyanine Green Injection

Zydus has received US Food and Drug Administration (FDA) approval for generic Indocyanine Green Injection, expanding its injectable imaging portfolio and functional dyes business.

ANDA Approval | 06/08/2026 | By News Bureau |  117

Cipla Wins US FDA Approval for Generic Advair Diskus

Cipla has received US Food and Drug Administration (FDA) approval for its generic Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in all 3 strengths.

ANDA Approval | 29/07/2026 | By News Bureau

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 |  147

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 |  156

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 |  160

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 |  140

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 |  106