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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212408
Company: BIONPHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ENALAPRIL MALEATE ENALAPRIL MALEATE 1MG/ML SOLUTION;ORAL Prescription AB 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
08/10/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212408Orig1s000ltr.pdf

ENALAPRIL MALEATE

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 212894 AMNEAL
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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