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AMLODIPINE BESYLATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: IPCA LABS LTD · Approved 2026-09-22

Drug application

FDA Application #

ANDA210489

Application type

Abbreviated New Drug Application (Generic)

Brand name

AMLODIPINE BESYLATE

Generic name

Amlodipine Besylate

Active ingredients

AMLODIPINE BESYLATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

IPCA LABS LTD

First approval

2026-09-22

Source

Authoritative

Drugs@FDA application overview

Machine

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