Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019221
Company: BAUSCH
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VASERETIC | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| VASERETIC | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019221s050lbl.pdf | |
| 07/21/2017 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019221s047lbl.pdf | |
| 08/25/2015 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019221s045lbl.pdf | |
| 12/24/2014 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019221s044lbl.pdf | |
| 09/13/2012 | SUPPL-43 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019221s043lbl.pdf | |
| 02/17/2012 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019221s042lbl.pdf | |
| 03/11/2011 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019221s041lbl.pdf | |
| 11/27/2001 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_prntlbl.pdf |