Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076653
Company: DR REDDYS
Company: DR REDDYS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUCONAZOLE IN SODIUM CHLORIDE 0.9% | FLUCONAZOLE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| FLUCONAZOLE IN SODIUM CHLORIDE 0.9% | 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/2004/76653ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076653_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/29/2013 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/16/2009 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |