Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUCONAZOLE | FLUCONAZOLE | 50MG/5ML | FOR SUSPENSION;ORAL | Discontinued | None | No | No |
FLUCONAZOLE | FLUCONAZOLE | 200MG/5ML | FOR SUSPENSION;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/2004/76246ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/27/2023 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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09/27/2023 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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09/27/2023 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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09/27/2023 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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09/27/2023 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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09/27/2023 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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09/27/2023 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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03/19/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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03/19/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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03/19/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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01/25/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
01/25/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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01/25/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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01/07/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
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12/06/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |