Drugs@FDA: FDA-Approved Drugs
Company: VALEANT INTL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RETIN-A | TRETINOIN | 0.025% | 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 |
---|---|---|---|---|---|---|---|
04/18/1975 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/14/2013 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/20/2001 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
06/10/2002 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf | |
01/25/1999 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/23/1998 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/10/2002 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf | |
06/10/2002 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf | |
01/31/1992 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/03/1990 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/28/1990 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
08/28/1990 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
12/01/1989 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
06/11/1985 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/23/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/30/1982 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
07/29/1981 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/28/1980 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
10/23/1979 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/01/1978 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
06/14/1977 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
01/04/1977 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/10/2002 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf | |
06/10/2002 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf | |
06/10/2002 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf |
RETIN-A
GEL;TOPICAL; 0.025%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RETIN-A | TRETINOIN | 0.025% | GEL;TOPICAL | Prescription | Yes | AB | 017579 | VALEANT INTL |
TRETINOIN | TRETINOIN | 0.025% | GEL;TOPICAL | Prescription | No | AB | 075529 | PADAGIS US |