Drugs@FDA: FDA-Approved Drugs
Company: VALEANT INTL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RETIN-A MICRO | TRETINOIN | 0.1% | GEL;TOPICAL | Prescription | None | Yes | Yes |
RETIN-A MICRO | TRETINOIN | 0.04% | GEL;TOPICAL | Prescription | None | Yes | Yes |
RETIN-A-MICRO | TRETINOIN | 0.08% | GEL;TOPICAL | Prescription | AB | Yes | Yes |
RETIN-A-MICRO | TRETINOIN | 0.06% | GEL;TOPICAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
02/07/1997 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020475ap.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/21/2014 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/29/2014 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/28/2014 | SUPPL-21 | Manufacturing (CMC) |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020475s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/020475Org1s021.pdf | |
01/08/2013 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/26/2009 | SUPPL-13 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
05/10/2002 | SUPPL-8 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20475s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20475s008ltr.pdf | |
03/20/2001 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/27/2000 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
04/05/2000 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/10/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/23/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/13/1998 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/13/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/28/2014 | SUPPL-21 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020475s021lbl.pdf |
05/10/2002 | SUPPL-8 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20475s8lbl.pdf |
RETIN-A MICRO
There are no Therapeutic Equivalents.
RETIN-A-MICRO
GEL;TOPICAL; 0.08%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RETIN-A-MICRO | TRETINOIN | 0.08% | GEL;TOPICAL | Prescription | Yes | AB | 020475 | VALEANT INTL |
TRETINOIN MICROSPHERE | TRETINOIN | 0.08% | GEL;TOPICAL | Prescription | No | AB | 215609 | ENCUBE |