Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070639
Company: INTL MEDICATION

Products on ANDA 070639

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	0.4MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070639

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/17/1986	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
05/18/2023	SUPPL-19	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
07/26/2013	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
05/29/2015	SUPPL-16	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
07/18/2002	SUPPL-14	Labeling		Label is not available on this site.
07/18/2002	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
06/10/1996	SUPPL-12	Labeling		Label is not available on this site.
09/19/1995	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
02/09/1995	SUPPL-10	Labeling		Label is not available on this site.
06/17/1994	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
01/14/1998	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/29/1993	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/20/1988	SUPPL-4	Labeling		Label is not available on this site.
02/06/1987	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/09/1986	SUPPL-2	Labeling		Label is not available on this site.
02/24/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.