Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022320
Company: GALDERMA LABS LP
Company: GALDERMA LABS LP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EPIDUO | ADAPALENE; BENZOYL PEROXIDE | 0.1%;2.5% | GEL;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 |
---|---|---|---|---|---|---|---|
12/08/2008 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022320lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022320s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022320_epiduo_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022320s000_SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/01/2014 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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07/01/2014 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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02/15/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/01/2013 | SUPPL-4 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022320s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022320Orig1s004ltr.pdf | |
12/14/2011 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022320s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022320s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/22320Orig1s002.pdf | |
02/18/2011 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022320s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022320s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/01/2013 | SUPPL-4 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022320s004lbl.pdf | |
12/14/2011 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022320s002lbl.pdf | |
02/18/2011 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022320s001lbl.pdf | |
12/08/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022320lbl.pdf |
EPIDUO
GEL;TOPICAL; 0.1%;2.5%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ADAPALENE AND BENZOYL PEROXIDE | ADAPALENE; BENZOYL PEROXIDE | 0.1%;2.5% | GEL;TOPICAL | Prescription | No | AB | 206164 | ENCUBE |
ADAPALENE AND BENZOYL PEROXIDE | ADAPALENE; BENZOYL PEROXIDE | 0.1%;2.5% | GEL;TOPICAL | Prescription | No | AB | 208108 | GLENMARK PHARMS LTD |
ADAPALENE AND BENZOYL PEROXIDE | ADAPALENE; BENZOYL PEROXIDE | 0.1%;2.5% | GEL;TOPICAL | Prescription | No | AB | 205033 | PADAGIS ISRAEL |
ADAPALENE AND BENZOYL PEROXIDE | ADAPALENE; BENZOYL PEROXIDE | 0.1%;2.5% | GEL;TOPICAL | Prescription | No | AB | 206959 | TARO |
EPIDUO | ADAPALENE; BENZOYL PEROXIDE | 0.1%;2.5% | GEL;TOPICAL | Prescription | Yes | AB | 022320 | GALDERMA LABS LP |