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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208686
Company: AZURITY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EPANED ENALAPRIL MALEATE 1MG/ML SOLUTION;ORAL Prescription AB Yes 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
09/20/2016 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208686s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208686Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208686Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/28/2017 SUPPL-2 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208686s002lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/28/2017 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208686s002lbl.pdf
09/20/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208686s000lbl.pdf

EPANED

SOLUTION;ORAL; 1MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ENALAPRIL MALEATE ENALAPRIL MALEATE 1MG/ML SOLUTION;ORAL Prescription No AB 213714 ALKEM LABS LTD
ENALAPRIL MALEATE ENALAPRIL MALEATE 1MG/ML SOLUTION;ORAL Prescription No AB 214467 ANNORA PHARMA
ENALAPRIL MALEATE ENALAPRIL MALEATE 1MG/ML SOLUTION;ORAL Prescription No AB 212408 BIONPHARMA INC
EPANED ENALAPRIL MALEATE 1MG/ML SOLUTION;ORAL Prescription Yes AB 208686 AZURITY
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