Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203110
Company: XGEN PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 20MG/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
06/29/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203110Orig1s000ltr.pdf

HYDRALAZINE HYDROCHLORIDE

INJECTABLE;INJECTION; 20MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription No AP 040730 AKORN
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription No AP 040388 FRESENIUS KABI USA
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription No AP 204680 MYLAN INSTITUTIONAL
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription No AP 202938 NAVINTA LLC
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE;INJECTION Prescription No AP 203110 XGEN PHARMS

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