Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070639
Company: INTL MEDICATION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription AP No No
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
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.

NALOXONE HYDROCHLORIDE

INJECTABLE;INJECTION; 0.4MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NALOXONE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 070299 WEST-WARD PHARMS INT
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 208871 AKORN
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 208872 AKORN
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 070172 HOSPIRA
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 070254 HOSPIRA
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 070256 HOSPIRA
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 070257 HOSPIRA
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 070639 INTL MEDICATION
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 204997 MYLAN INSTITUTIONAL
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 205014 MYLAN INSTITUTIONAL
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 207846 RENAISSANCE SSA LLC
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 207633 SOMERSET THERAPS LLC
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 207634 SOMERSET THERAPS LLC

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