← FDA Drug Approvals (Drugs@FDA)

AMLODIPINE BESYLATE AND VALSARTAN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMS LTD · Approved 2024-10-11

Drug application

FDA Application #

ANDA207292

Application type

Abbreviated New Drug Application (Generic)

Brand name

AMLODIPINE BESYLATE AND VALSARTAN

Generic name

AMLODIPINE AND VALSARTAN

Active ingredients

AMLODIPINE BESYLATE; VALSARTAN

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

MACLEODS PHARMS LTD

Manufacturer

Macleods Pharmaceuticals Limited

First approval

2024-10-11

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown