Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019221
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
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
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 075727 ACP NIMBLE
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 075624 MYLAN
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10MG;25MG TABLET;ORAL Prescription No AB 076486 NOSTRUM LABS INC
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 075727 ACP NIMBLE
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 075624 MYLAN
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 5MG;12.5MG TABLET;ORAL Prescription No AB 076486 NOSTRUM LABS INC
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

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