Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207846
Company: RENAISSANCE SSA LLC
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
12/17/2018 ORIG-1 Approval STANDARD

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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