Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018998
Company: BAUSCH
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VASOTEC | ENALAPRIL MALEATE | 5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| VASOTEC | ENALAPRIL MALEATE | 10MG | TABLET;ORAL | Prescription | AB | Yes | No |
| VASOTEC | ENALAPRIL MALEATE | 20MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| VASOTEC | ENALAPRIL MALEATE | 2.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/24/1985 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_Vasotec.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/01/2018 | SUPPL-83 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018998s083lbl.pdf | |
| 07/21/2017 | SUPPL-82 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018998s082lbl.pdf | |
| 08/25/2015 | SUPPL-80 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018998s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018998Orig1s080ltr.pdf | |
| 12/24/2014 | SUPPL-79 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018998s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018998Orig1s079ltr.pdf | |
| 09/13/2012 | SUPPL-77 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018998s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018998Origs077ltr.pdf | |
| 02/17/2012 | SUPPL-76 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018998s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018998s076ltr.pdf | |
| 09/25/2008 | SUPPL-71 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018998s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018998s071, 019221s038ltr.pdf | |
| 10/31/2007 | SUPPL-70 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018998s070, 019221s037ltr.pdf |
| 10/10/2002 | SUPPL-64 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018998_S064_Vasotec_APPROVAL PACKAGE.pdf |
| 08/30/2002 | SUPPL-63 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18998scm063ltr.pdf |
| 04/03/2002 | SUPPL-62 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018998_S062_Vasotec_APPROVAL_PACKAGE.pdf |
| 02/04/2002 | SUPPL-61 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018998_S061_Vasotec_APPROVAL PACKAGE.pdf |
| 02/13/2001 | SUPPL-59 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S059_Vasotec_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S059_Vasotec_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S059_Vasotec.cfm | |
| 11/27/2001 | SUPPL-58 | 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-57 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf |
| 12/10/1997 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1997 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1997 | SUPPL-54 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/11/1997 | SUPPL-53 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019309_s021ap.pdf |
| 02/03/1997 | SUPPL-52 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/018998_S052_VASOTEC_AP.pdf |
| 01/09/1997 | SUPPL-51 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018998_S051_VASOTEC_AP.pdf |
| 03/22/1996 | SUPPL-50 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018998_S050_VASOTEC_AP.pdf |
| 09/19/1995 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/19/1995 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/19/1995 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/28/1995 | SUPPL-46 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S046_VASOTEC_AP.pdf |
| 07/25/1994 | SUPPL-45 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S045_VASOTEC_AP.pdf |
| 05/16/1994 | SUPPL-44 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_s044_vasotec.pdf |
| 02/18/1994 | SUPPL-43 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_s043_vasotec.pdf |
| 07/15/1994 | SUPPL-42 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S042_VASOTEC_AP.pdf |
| 12/12/1994 | SUPPL-41 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S041_VASOTEC_AP.pdf |
| 10/21/1993 | SUPPL-40 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_s040_vasotec.pdf |
| 01/14/1994 | SUPPL-39 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_s039_vasotec.pdf |
| 05/11/1994 | SUPPL-38 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_s038_vasotec.pdf |
| 07/01/1993 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 02/24/1993 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 07/26/1993 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1996 | SUPPL-34 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018998_S034_VASOTEC_AP.pdf |
| 09/30/1992 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 11/04/1993 | SUPPL-32 | Efficacy-New Indication |
Label is not available on this site. |
||
| 05/07/1992 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 05/13/1992 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 09/30/1992 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/08/1992 | SUPPL-27 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 08/02/1991 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/06/1991 | SUPPL-25 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S025_VASOTEC.pdf |
| 11/28/1990 | SUPPL-24 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S024_VASOTEC.pdf |
| 07/19/1990 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S023_VASOTEC.pdf |
| 06/12/1990 | SUPPL-22 | Efficacy-New Indication |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S022_VASOTEC.pdf |
| 03/09/1990 | SUPPL-21 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S021_VASOTEC.pdf |
| 11/30/1989 | SUPPL-20 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S020_VASOTEC_AP.pdf |
| 04/18/1989 | SUPPL-18 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S018_VASOTEC_AP.pdf |
| 02/20/1991 | SUPPL-17 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S017_VASOTEC.pdf |
| 01/10/1989 | SUPPL-16 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S016_VASOTEC.pdf |
| 03/29/1989 | SUPPL-15 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S015_ VASOTEC_AP.pdf |
| 08/03/1988 | SUPPL-13 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S013_VASOTEC.pdf |
| 07/26/1988 | SUPPL-12 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/25/1988 | SUPPL-11 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S011_VASOTEC.pdf |
| 07/10/1987 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S009_Vasotec_APPROVAL PACKAGE.pdf |
| 06/24/1988 | SUPPL-7 | Efficacy-New Indication |
Label is not available on this site. |
||
| 01/28/1987 | SUPPL-6 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S006_Vasotec_APPROVAL PACKAGE.pdf |
| 05/14/1987 | SUPPL-5 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S005_Vasotec_APPROVAL PACKAGE.pdf |
| 10/03/1986 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/07/1986 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/27/1986 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/01/2018 | SUPPL-83 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018998s083lbl.pdf | |
| 07/21/2017 | SUPPL-82 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018998s082lbl.pdf | |
| 08/25/2015 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018998s080lbl.pdf | |
| 12/24/2014 | SUPPL-79 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018998s079lbl.pdf | |
| 09/13/2012 | SUPPL-77 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018998s077lbl.pdf | |
| 02/17/2012 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018998s076lbl.pdf | |
| 09/25/2008 | SUPPL-71 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018998s071lbl.pdf | |
| 11/27/2001 | SUPPL-58 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_prntlbl.pdf | |
| 02/13/2001 | SUPPL-59 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S059_Vasotec_prntlbl.pdf |
VASOTEC
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 5MG | TABLET;ORAL | Prescription | No | AB | 075479 | HERITAGE PHARMA |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 5MG | TABLET;ORAL | Prescription | No | AB | 213273 | PRINSTON INC |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 5MG | TABLET;ORAL | Prescription | No | AB | 075496 | SANDOZ INC |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 5MG | TABLET;ORAL | Prescription | No | AB | 075657 | TARO |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 5MG | TABLET;ORAL | Prescription | No | AB | 075483 | WOCKHARDT LTD |
| VASOTEC | ENALAPRIL MALEATE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 018998 | BAUSCH |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 10MG | TABLET;ORAL | Prescription | No | AB | 075479 | HERITAGE PHARMA |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 10MG | TABLET;ORAL | Prescription | No | AB | 213273 | PRINSTON INC |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 10MG | TABLET;ORAL | Prescription | No | AB | 075459 | SANDOZ INC |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 10MG | TABLET;ORAL | Prescription | No | AB | 075657 | TARO |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 10MG | TABLET;ORAL | Prescription | No | AB | 075483 | WOCKHARDT LTD |
| VASOTEC | ENALAPRIL MALEATE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 018998 | BAUSCH |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 20MG | TABLET;ORAL | Prescription | No | AB | 075479 | HERITAGE PHARMA |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 20MG | TABLET;ORAL | Prescription | No | AB | 213273 | PRINSTON INC |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 20MG | TABLET;ORAL | Prescription | No | AB | 075459 | SANDOZ INC |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 20MG | TABLET;ORAL | Prescription | No | AB | 075657 | TARO |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 20MG | TABLET;ORAL | Prescription | No | AB | 075483 | WOCKHARDT LTD |
| VASOTEC | ENALAPRIL MALEATE | 20MG | TABLET;ORAL | Prescription | Yes | AB | 018998 | BAUSCH |
TABLET;ORAL; 2.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 075479 | HERITAGE PHARMA |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 213273 | PRINSTON INC |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 075496 | SANDOZ INC |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 075657 | TARO |
| ENALAPRIL MALEATE | ENALAPRIL MALEATE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 075483 | WOCKHARDT LTD |
| VASOTEC | ENALAPRIL MALEATE | 2.5MG | TABLET;ORAL | Prescription | Yes | AB | 018998 | BAUSCH |