Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075374
Company: AVONDALE PHARMS
Company: AVONDALE PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIFLORASONE DIACETATE | DIFLORASONE DIACETATE | 0.05% | OINTMENT;TOPICAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 04/27/1999 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-374_Diflorasone%20Diacetate_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75374ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-374_Diflorasone.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/14/2019 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/14/2019 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/12/2005 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/02/2003 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/19/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/27/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-374_Diflorasone%20Diacetate_prntlbl.pdf |
DIFLORASONE DIACETATE
OINTMENT;TOPICAL; 0.05%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIFLORASONE DIACETATE | DIFLORASONE DIACETATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 075374 | AVONDALE PHARMS |
| DIFLORASONE DIACETATE | DIFLORASONE DIACETATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 207440 | RISING |
| DIFLORASONE DIACETATE | DIFLORASONE DIACETATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 075331 | SUN PHARMA CANADA |
| DIFLORASONE DIACETATE | DIFLORASONE DIACETATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 210753 | THE J MOLNER |