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HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SPECGX LLC · Approved 2017-03-31

Drug application

FDA Application #
ANDA206718
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
Prescription
Sponsor
SPECGX LLC
Manufacturer
SpecGx LLC
First approval
2017-03-31

Source

Authoritative
Drugs@FDA application overview
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