Drugs@FDA: FDA-Approved Drugs
Company: VALEANT PHARMS NORTH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RETIN-A | TRETINOIN | 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 |
|---|---|---|---|---|---|---|---|
| 01/26/1973 | 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 |
|---|---|---|---|---|---|
| 05/13/2016 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/2015 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/2013 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/2002 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/2001 | SUPPL-37 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/10/2002 | SUPPL-36 | 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-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1998 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/2002 | SUPPL-33 | 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-32 | 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 | |
| 01/24/1992 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/03/1990 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1990 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 08/28/1990 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 12/01/1989 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/12/1989 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 08/26/1986 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/11/1985 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/1986 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1984 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/06/1983 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/1981 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/13/1982 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 12/04/1978 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 01/04/1977 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 06/30/1976 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1974 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/15/1974 | SUPPL-9 |
Label is not available on this site. |
|||
| 04/15/1974 | SUPPL-7 |
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-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf | |
| 06/10/2002 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf | |
| 06/10/2002 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf |
RETIN-A
CREAM;TOPICAL; 0.1%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RETIN-A | TRETINOIN | 0.1% | CREAM;TOPICAL | Prescription | Yes | AB | 017340 | VALEANT PHARMS NORTH |
| TRETINOIN | TRETINOIN | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 217804 | ALEMBIC |
| TRETINOIN | TRETINOIN | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 075213 | PADAGIS US |
| TRETINOIN | TRETINOIN | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 211645 | TARO |
| TRETINOIN | TRETINOIN | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 218561 | ZYDUS LIFESCIENCES |