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DILTIAZEM HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TWI PHARMS · Approved 2018-08-30

Drug application

FDA Application #

ANDA205231

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

TWI PHARMS

Manufacturer

Upsher-Smith Laboratories, LLC

First approval

2018-08-30

Source

Authoritative

Drugs@FDA application overview

Machine

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