Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075508
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIFLORASONE DIACETATE | DIFLORASONE DIACETATE | 0.05% | CREAM;TOPICAL | Prescription | BX | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/24/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75508ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/28/2016 | SUPPL-14 | Labeling-Proprietary Name Change |
Label is not available on this site. |
||
07/28/2016 | SUPPL-13 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
10/15/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/29/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
DIFLORASONE DIACETATE
There are no Therapeutic Equivalents.