Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078369
Company: FOUGERA PHARMS
Company: FOUGERA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DESOXIMETASONE | DESOXIMETASONE | 0.25% | CREAM;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 |
---|---|---|---|---|---|---|---|
06/29/2010 | 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 |
---|---|---|---|---|---|
06/14/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
11/13/2014 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
DESOXIMETASONE
CREAM;TOPICAL; 0.25%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DESOXIMETASONE | DESOXIMETASONE | 0.25% | CREAM;TOPICAL | Prescription | No | AB | 205082 | ACTAVIS MID ATLANTIC |
DESOXIMETASONE | DESOXIMETASONE | 0.25% | CREAM;TOPICAL | Prescription | No | AB | 078369 | FOUGERA PHARMS |
DESOXIMETASONE | DESOXIMETASONE | 0.25% | CREAM;TOPICAL | Prescription | No | AB | 208164 | LUPIN |
DESOXIMETASONE | DESOXIMETASONE | 0.25% | CREAM;TOPICAL | Prescription | No | AB | 076510 | PADAGIS ISRAEL |
DESOXIMETASONE | DESOXIMETASONE | 0.25% | CREAM;TOPICAL | Prescription | No | AB | 205594 | RISING |
DESOXIMETASONE | DESOXIMETASONE | 0.25% | CREAM;TOPICAL | Prescription | No | AB | 205620 | ZYDUS LIFESCIENCES |
TOPICORT | DESOXIMETASONE | 0.25% | CREAM;TOPICAL | Prescription | No | AB | 073193 | TARO |