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FDA ANDA · ANDA206586

BUPRENORPHINE HYDROCHLORIDE

Sponsor: PH HEALTH

APPLICATION
ANDA206586
TYPE
ANDA
ORIGINAL APPROVAL
2015-07-28
LATEST ACTION
2025-12-29
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BUPRENORPHINE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML · INJECTABLE · INJECTION

Approval history

2025-12-29Labeling · Supplement 15 · standardAP
2025-07-29Labeling · Supplement 11 · standardAP
2025-07-29Labeling · Supplement 14 · standardAP
2020-06-23Labeling · Supplement 5 · standardAP
2020-06-23Labeling · Supplement 1 · standardAP
2015-07-28UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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