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FDA ANDA · ANDA075735
PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Sponsor: LUPIN
APPLICATION
ANDA075735
TYPE
ANDA
ORIGINAL APPROVAL
2001-07-11
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 27AP
2026-01-23Labeling · Supplement 24 · standardAP
2026-01-23Labeling · Supplement 23 · standardAP
2024-10-31REMS · Supplement 22AP
2024-01-03Labeling · Supplement 19 · standardAP
2024-01-03Labeling · Supplement 21 · standardAP
2021-03-04Labeling · Supplement 16 · standardAP
2019-10-09Labeling · Supplement 15 · standardAP
2018-09-20Labeling · Supplement 14 · standardAP
2018-09-18REMS · Supplement 13AP
2017-04-20Labeling · Supplement 12 · standardAP
2017-04-20Labeling · Supplement 11 · standardAP
2015-01-07Labeling · Supplement 8AP
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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