Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020748
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% | CREAM;TOPICAL | Prescription | AB | Yes | 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 |
---|---|---|---|---|---|---|---|
05/26/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20748lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20748ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020748_differin.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/01/2014 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/08/2013 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/25/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/26/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20748lbl.pdf |
DIFFERIN
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 |