Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072076
Company: INTL MEDICATION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE;INJECTION Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/24/1988 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
07/31/2015 SUPPL-19 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

10/30/2013 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

06/04/2008 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

07/18/2002 SUPPL-13 Labeling

Label is not available on this site.

07/18/2002 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1996 SUPPL-11 Labeling

Label is not available on this site.

09/19/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/17/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/06/1995 SUPPL-8 Labeling

Label is not available on this site.

01/14/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/29/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/20/1988 SUPPL-2 Labeling

Label is not available on this site.

04/22/1988 SUPPL-1 Labeling

Label is not available on this site.

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