← FDA Drug Approvals (Drugs@FDA)

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROLIFE PHARMA LLC · Approved 2012-04-11

Drug application

FDA Application #

ANDA201013

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

AUROLIFE PHARMA LLC

Manufacturer

Aurolife Pharma, LLC

First approval

2012-04-11

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown