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HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UPSHER SMITH LABS · Approved 2017-03-24

Drug application

FDA Application #
ANDA206484
Application type
Abbreviated New Drug Application (Generic)
Brand name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Generic name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Active ingredients
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Dosage form
TABLET
Route
ORAL
Marketing status
Discontinued
Sponsor
UPSHER SMITH LABS
Manufacturer
Upsher-Smith Laboratories, LLC
First approval
2017-03-24

Source

Authoritative
Drugs@FDA application overview
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