Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075331
Company: TARO
Company: TARO
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 | 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 |
---|---|---|---|---|---|---|---|
05/14/1999 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/08/2003 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/29/2000 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/01/1999 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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 | TARO |
DIFLORASONE DIACETATE | DIFLORASONE DIACETATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 210753 | THE J MOLNER |