Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022070
Company: DOW PHARM
Company: DOW PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ATRALIN | TRETINOIN | 0.05% | 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 |
---|---|---|---|---|---|---|---|
07/26/2007 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022070s000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022070_atralin_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/05/2015 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/29/2014 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022070s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022070Orig1s003ltr.pdf | |
03/06/2008 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/29/2014 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022070s003lbl.pdf | |
07/26/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022070lbl.pdf |
ATRALIN
GEL;TOPICAL; 0.05%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATRALIN | TRETINOIN | 0.05% | GEL;TOPICAL | Prescription | Yes | AB | 022070 | DOW PHARM |
TRETINOIN | TRETINOIN | 0.05% | GEL;TOPICAL | Prescription | No | AB | 207955 | MYLAN |