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FDA ANDA · ANDA204383

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Sponsor: ACTAVIS LABS UT INC

APPLICATION
ANDA204383
TYPE
ANDA
ROUTE
BUCCAL, SUBLINGUAL
DOSAGE FORM
FILM
MARKETING STATUS
None (Tentative Approval)

Products

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDENone (Tentative Approval)
BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE, NALOXONE HYDROCHLORIDE EQ 2MG BASE · FILM · BUCCAL, SUBLINGUAL

Approval history

2017-10-24UNKNOWN · Original · standard — Letter ↗TA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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