Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018998
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 075178 NOSTRUM LABS 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 075178 NOSTRUM LABS 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 075178 NOSTRUM LABS 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 075178 NOSTRUM LABS 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

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