News about "ANDA approval"

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 |  101

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

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 |  106

Alembic Pharmaceuticals Gets US FDA Nod for Methotrexate Injection

Alembic Pharmaceuticals secures USFDA approval for Methotrexate Injection USP in multi-dose and single-dose vials, a key folate analog metabolic inhibitor used in the treatment of various neoplastic diseases.

ANDA Approval | 17/04/2026 | By News Bureau

Orbicular Pharmaceutical Technologies, Gland Pharma and Apotex Secure US FDA Approval for Generic Infuvite Adult

The partnership among Orbicular Pharmaceutical Technologies, Gland Pharma and Apotex, achieves first ANDA approval with Competitive Generic Therapy designation, gaining six-month exclusivity for complex multivitamin injectable in the United States.

ANDA Approval | 16/04/2026 | By News Bureau |  156

Inventia Healthcare Launches Generic Dapagliflozin in US After FDA Approval

Inventia Healthcare has secured FDA approval for dapagliflozin tablets and begun Day-One commercialisation, expanding access to affordable diabetes and heart failure treatment in the US.

ANDA Approval | 09/04/2026 | By News Bureau |  163