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BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN TECHNOLOGIES · Approved 2020-04-17

Drug application

FDA Application #
ANDA211785
Application type
Abbreviated New Drug Application (Generic)
Brand name
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Generic name
BUPRENORPHINE AND NALOXONE
Active ingredients
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Dosage form
FILM
Route
BUCCAL, SUBLINGUAL
Marketing status
Prescription
Sponsor
MYLAN TECHNOLOGIES
Manufacturer
Mylan Pharmaceuticals Inc.
First approval
2020-04-17

Source

Authoritative
Drugs@FDA application overview
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