Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020312
Company: UCB INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
UNIVASC MOEXIPRIL HYDROCHLORIDE 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
UNIVASC MOEXIPRIL HYDROCHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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
04/19/1995 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020312Orig1s000rev.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-312_Moexipril_Univasc.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/14/2012 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020312s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020312Orig1s035ltr.pdf
01/19/2012 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020312s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020312s034,020729s025ltr.pdf
08/23/2011 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020312s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020312s033ltr.pdf
01/13/2010 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020312s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020312s031ltr.pdf
10/29/2003 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20312slr012,20312slr024ltr.pdf
12/09/2002 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/02/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

04/11/2001 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20312S16ltr.pdf
03/28/2001 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/02/2000 SUPPL-14 Labeling

Label is not available on this site.

07/18/2000 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/29/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/11/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/08/1998 SUPPL-10 Labeling

Label is not available on this site.

09/03/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/08/1996 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/03/1996 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/09/1996 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/18/1995 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/18/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/18/1995 SUPPL-1 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
09/14/2012 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020312s035lbl.pdf
01/19/2012 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020312s034lbl.pdf
08/23/2011 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020312s033lbl.pdf
01/13/2010 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020312s031lbl.pdf

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