Drugs@FDA: FDA-Approved Drugs
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| VASOTEC | ENALAPRILAT | 1.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |