Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070254
Company: HOSPIRA
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 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
01/07/1987 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
12/13/2006 SUPPL-9 Labeling

Label is not available on this site.

08/08/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/27/1993 SUPPL-6 Labeling

Label is not available on this site.

07/31/1990 SUPPL-4 Labeling

Label is not available on this site.

07/11/1991 SUPPL-2 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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