Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070172
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
04/18/1986 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
02/23/2004 SUPPL-6 Labeling

Label is not available on this site.

02/14/2001 SUPPL-4 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/22/1995 SUPPL-3 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/26/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/19/1992 SUPPL-1 Labeling

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 212455 AUROBINDO PHARMA LTD
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 212456 AUROBINDO PHARMA LTD
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 207633 SOMERSET THERAPS LLC
NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE;INJECTION Prescription No AP 207634 SOMERSET THERAPS LLC

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