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HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AVANTHI INC · Approved 2017-08-07

Drug application

FDA Application #

ANDA207176

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

Prescription

Sponsor

AVANTHI INC

Manufacturer

KVK-Tech, Inc.

First approval

2017-08-07

Source

Authoritative

Drugs@FDA application overview

Machine

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