Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075644
Company: TEVA PHARMS
Company: TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/26/2001 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/13/2015 | SUPPL-26 | Labeling-Container/Carton Labels, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/27/2008 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 12/08/2006 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 05/04/2006 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 08/28/2002 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/28/2002 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/28/2002 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/28/2002 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/28/2002 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/28/2002 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/28/2002 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/28/2002 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/28/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/28/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/28/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |