Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208686
Company: AZURITY
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 | 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 | 216458 | AUROBINDO PHARMA |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AB | 212408 | BIONPHARMA |
| EPANED | ENALAPRIL MALEATE | 1MG/ML | SOLUTION;ORAL | Prescription | Yes | AB | 208686 | AZURITY |