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DILTIAZEM HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2017-08-08

Drug application

FDA Application #

ANDA206534

Application type

Abbreviated New Drug Application (Generic)

Brand name

DILTIAZEM HYDROCHLORIDE

Generic name

DILTIAZEM HYDROCHLORIDE

Active ingredients

DILTIAZEM HYDROCHLORIDE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

ZYDUS PHARMS

Manufacturer

Zydus Pharmaceuticals (USA) Inc.

First approval

2017-08-08

Source

Authoritative

Drugs@FDA application overview

Machine

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