Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076304
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | FLUCONAZOLE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | FLUCONAZOLE | 400MG/200ML (2MG/ML) | INJECTABLE;INJECTION | 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)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76304ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076304_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/17/2023 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/17/2023 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/12/2021 | SUPPL-23 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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| 05/12/2021 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/12/2021 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/12/2021 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/12/2021 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/12/2021 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/24/2014 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/25/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 05/11/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |