Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020338
Company: GALDERMA LABS LP
Company: GALDERMA LABS LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIFFERIN | ADAPALENE | 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;TOPICAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 05/31/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020338Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/08/2002 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/10/1999 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/12/1998 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |