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BUPRENORPHINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 2009-10-08

Drug application

FDA Application #
ANDA078633
Application type
Abbreviated New Drug Application (Generic)
Brand name
BUPRENORPHINE HYDROCHLORIDE
Generic name
BUPRENORPHINE
Active ingredients
BUPRENORPHINE HYDROCHLORIDE
Dosage form
TABLET
Route
SUBLINGUAL
Marketing status
Prescription
Sponsor
HIKMA
Manufacturer
Hikma Pharmaceuticals USA Inc.
First approval
2009-10-08

Source

Authoritative
Drugs@FDA application overview
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