Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074736
Company: WATSON LABS

• REMS

Products on ANDA 074736

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074736

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/21/1997	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-40	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-38	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-36	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/10/2019	SUPPL-35	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/21/2018	SUPPL-34	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-33	REMS - PROPOSAL - D-N-A		Label is not available on this site.
08/15/2018	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-29	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2016	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
03/23/2004	SUPPL-8	Labeling		Label is not available on this site.
02/20/2004	SUPPL-7	Labeling		Label is not available on this site.
04/12/2001	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
03/21/2000	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
03/22/1999	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074736

NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE

TABLET;ORAL; EQ 0.5MG BASE;EQ 50MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	075735	LUPIN
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	075523	SUN PHARM INDS LTD
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	074736	WATSON LABS