Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019982
Company: TEVA WOMENS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZEBETA BISOPROLOL FUMARATE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ZEBETA BISOPROLOL FUMARATE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
07/31/1992 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19982_Zebeta.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/12/2014 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/28/2013 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/03/2011 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019982s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019982s016ltr.pdf
09/25/2007 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019982s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019982s014, 020186s023ltr.pdf
01/24/2003 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20186slr015,19982slr010ltr.pdf
04/04/2000 SUPPL-7 Labeling

Label is not available on this site.

02/19/1998 SUPPL-6 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19982-S6_Zebeta.pdf
06/23/1998 SUPPL-5 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19982-S5_Zebeta.pdf
01/14/1997 SUPPL-4 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/19982-S4_Zebeta.pdf
05/30/1995 SUPPL-3 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19982-S3_Zebeta.pdf
06/11/1993 SUPPL-1 Manufacturing (CMC)-Expiration Date Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19982-S1_Zebeta.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/03/2011 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019982s016lbl.pdf
09/25/2007 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019982s014lbl.pdf

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