Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074681
Company: TEVA
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET;ORAL | Discontinued | None | No | No |
FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET;ORAL | Discontinued | None | No | No |
FLUCONAZOLE | FLUCONAZOLE | 200MG | 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 |
---|---|---|---|---|---|---|---|
07/29/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/74681ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/15/2022 | SUPPL-12 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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04/09/2021 | SUPPL-11 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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04/09/2021 | SUPPL-10 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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04/09/2021 | SUPPL-9 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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04/10/2008 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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02/06/2008 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/06/2008 | SUPPL-6 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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02/06/2008 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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08/29/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |