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HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVEL LABS INC · Approved 2011-04-20

Drug application

FDA Application #

ANDA091528

Application type

Abbreviated New Drug Application (Generic)

Brand name

HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE

Generic name

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

Active ingredients

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

Dosage form

TABLET

Route

ORAL

Marketing status

Discontinued

Sponsor

NOVEL LABS INC

Manufacturer

Lupin Pharmaceuticals,Inc.

First approval

2011-04-20

Source

Authoritative

Drugs@FDA application overview

Machine

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