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AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2025-05-22

Drug application

FDA Application #

ANDA217279

Application type

Abbreviated New Drug Application (Generic)

Brand name

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

Generic name

AMLODIPINE AND ATORVASTATIN

Active ingredients

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ALEMBIC

Manufacturer

Alembic Pharmaceuticals Inc.

First approval

2025-05-22

Source

Authoritative

Drugs@FDA application overview

Machine

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