Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040136
Company: LUITPOLD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE;INJECTION Discontinued None 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
06/30/1997 ORIG-1 Approval Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/040136_hydralazine_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/26/2013 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040136s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/040136s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/26/2013 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040136s005lbl.pdf

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