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TIZANIDINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2020-01-13

Drug application

FDA Application #

ANDA213223

Application type

Abbreviated New Drug Application (Generic)

Brand name

TIZANIDINE HYDROCHLORIDE

Generic name

TIZANIDINE HYDROCHLORIDE

Active ingredients

TIZANIDINE HYDROCHLORIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

ALEMBIC

Manufacturer

Alembic Pharmaceuticals Limited

First approval

2020-01-13

Source

Authoritative

Drugs@FDA application overview

Machine

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