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HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS MID ATLANTIC · Approved 1983-07-05

Drug application

FDA Application #
ANDA088017
Application type
Abbreviated New Drug Application (Generic)
Brand name
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
Generic name
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
Active ingredients
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
Dosage form
SYRUP
Route
ORAL
Marketing status
Prescription
Sponsor
ACTAVIS MID ATLANTIC
Manufacturer
Actavis Pharma, Inc.
First approval
1983-07-05

Source

Authoritative
Drugs@FDA application overview
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