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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/31/1986 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
| 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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019221s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019221Orig1s050ltr.pdf | |
| 07/21/2017 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019221s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019221Orig1s047ltr.pdf | |
| 08/25/2015 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019221s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019221Orig1s045ltr.pdf | |
| 12/24/2014 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019221s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019221Orig1s044ltr.pdf | |
| 09/13/2012 | SUPPL-43 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019221s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019221Orig1s043ltr.pdf | |
| 02/17/2012 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019221s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019221s042ltr.pdf | |
| 03/11/2011 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019221s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019221s041ltr.pdf | |
| 09/25/2008 | SUPPL-38 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018998s071, 019221s038ltr.pdf |
| 10/31/2007 | SUPPL-37 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018998s070, 019221s037ltr.pdf |
| 10/15/2002 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/2002 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/01/2002 | SUPPL-27 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19221slr027,19309slr025ltr.pdf |
| 11/27/2001 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998s058_Vasotec.cfm | |
| 02/17/1999 | SUPPL-25 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf |
| 10/13/1998 | SUPPL-24 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19221s024.pdf |
| 06/11/1997 | SUPPL-23 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019221_s023ap.pdf |
| 07/12/1995 | SUPPL-22 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/28/1995 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 07/25/1994 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 10/21/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 05/11/1994 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 01/14/1994 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 07/12/1995 | SUPPL-15 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 02/24/1993 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 07/31/1996 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/30/1992 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 05/13/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 05/07/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/30/1992 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/06/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/09/1990 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/30/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/22/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/1989 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 01/10/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 01/30/1987 | SUPPL-1 | Labeling |
Label is not available on this site. |
| 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 |
VASERETIC
TABLET;ORAL; 10MG;25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET;ORAL | Prescription | No | AB | 075909 | DR REDDYS LABS LTD |
| ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET;ORAL | Prescription | No | AB | 075788 | TARO PHARM INDS |
| VASERETIC | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 10MG;25MG | TABLET;ORAL | Prescription | Yes | AB | 019221 | BAUSCH |
TABLET;ORAL; 5MG;12.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 075909 | DR REDDYS LABS LTD |
| ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 075788 | TARO PHARM INDS |
| VASERETIC | ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE | 5MG;12.5MG | TABLET;ORAL | Prescription | Yes | AB | 019221 | BAUSCH |