Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076351
Company: PHARMOBEDIENT
Company: PHARMOBEDIENT
| 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/2004/76351ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/01/2024 | SUPPL-17 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 06/09/2022 | SUPPL-16 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/09/2022 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/25/2021 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/25/2021 | SUPPL-12 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/25/2021 | SUPPL-11 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/25/2021 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/25/2012 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/28/2010 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/17/2009 | SUPPL-6 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/20/2004 | SUPPL-1 | Labeling |
Label is not available on this site. |