Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090824
Company: FOUGERA PHARMS
Company: FOUGERA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ADAPALENE | ADAPALENE | 0.1% | 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 |
---|---|---|---|---|---|---|---|
06/30/2010 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090824s000ltr.pdf |
ADAPALENE
CREAM;TOPICAL; 0.1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ADAPALENE | ADAPALENE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 090824 | FOUGERA PHARMS |
DIFFERIN | ADAPALENE | 0.1% | CREAM;TOPICAL | Prescription | Yes | AB | 020748 | GALDERMA LABS LP |