Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019309
Company: BIOVAIL LABS INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VASOTEC ENALAPRILAT 1.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
02/09/1988 ORIG-1 Approval Type 2 - New Active Ingredient 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
11/25/2002 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

12/17/2001 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/2002 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19221slr027,19309slr025ltr.pdf
12/06/2000 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/2001 SUPPL-23 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-22 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf
06/11/1997 SUPPL-21 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019309_s021ap.pdf
10/27/1997 SUPPL-20 Labeling

Label is not available on this site.

09/28/1995 SUPPL-19 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S019_Vasotec I.V. Injection_APPROVAL PACKAGE.pdf
07/25/1994 SUPPL-18 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S018_Vasotec I.V. Injection_APPROVAL PACKAGE.pdf
02/18/1994 SUPPL-17 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S014_Vasotec I.V. Injection_Approval Package.pdf
10/21/1993 SUPPL-16 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S016_VASOTEC I.V. INJECTION.pdf
05/11/1994 SUPPL-15 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S015_Vasotec I.V. Injection_Approval Package.pdf
01/14/1994 SUPPL-14 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S014_Vasotec I.V. Injection_Approval Package.pdf
02/24/1993 SUPPL-13 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S013_VASOTEC I.V. INJECTION.pdf
07/31/1996 SUPPL-12 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019309_S012_Vasotec I.V. Injection_APPROVAL PACKAGE.pdf
09/30/1992 SUPPL-11 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S011_VASOTEC I.V.INJECTION.pdf
05/13/1992 SUPPL-10 Labeling

Label is not available on this site.

05/07/1992 SUPPL-9 Labeling

Label is not available on this site.

02/06/1991 SUPPL-8 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_s008_vasotec iv injection.pdf
01/29/1992 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 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_s005_vasotec IV injection.pdf
10/19/1989 SUPPL-4 Labeling

Label is not available on this site.

04/18/1989 SUPPL-3 Labeling

Label is not available on this site.

01/10/1989 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
11/27/2001 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_prntlbl.pdf

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