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FDA ANDA · ANDA074736
PENTAZOCINE AND NALOXONE
pentazocine hydrochloride and naloxone hydrochloride
Sponsor: WATSON LABS
APPLICATION
ANDA074736
TYPE
ANDA
ORIGINAL APPROVAL
1997-01-21
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEPrescription
NALOXONE HYDROCHLORIDE EQ 0.5MG BASE, PENTAZOCINE HYDROCHLORIDE EQ 50MG BASE · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 47AP
2025-12-22Labeling · Supplement 45 · standardAP
2025-12-15Labeling · Supplement 41 · standardAP
2024-10-31REMS · Supplement 42AP
2023-12-15Labeling · Supplement 38 · standardAP
2023-12-15Labeling · Supplement 40 · standardAP
2021-03-04Labeling · Supplement 36 · standardAP
2019-10-10Labeling · Supplement 35 · standardAP
2018-09-21Labeling · Supplement 34 · standardAP
2018-09-18REMS · Supplement 33AP
2018-08-15Labeling · Supplement 32 · standardAP
2016-12-16Labeling · Supplement 29 · standardAP
2016-12-16Labeling · Supplement 30 · standardAP
2016-12-15Labeling · Supplement 26 · standardAP
2004-03-23Labeling · Supplement 8AP
2004-02-20Labeling · Supplement 7AP
2001-04-12Manufacturing (CMC) · Supplement 6AP
2000-03-21Manufacturing (CMC) · Supplement 5AP
1999-03-22Manufacturing (CMC) · Supplement 3AP
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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