Drugs@FDA: FDA-Approved Drugs
Company: VALEANT BERMUDA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RETIN-A | TRETINOIN | 0.05% | CREAM;TOPICAL | Prescription | AB1 | 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 |
|---|---|---|---|---|---|---|---|
| 07/19/1974 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/2013 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/2002 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/2001 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/10/2002 | SUPPL-26 | 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-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1998 | SUPPL-24 | Manufacturing (CMC) |
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 | |
| 06/10/2002 | SUPPL-22 | 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-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/03/1990 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1990 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 08/28/1990 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 12/01/1989 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/26/1986 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/17/1985 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1986 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/1984 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/06/1983 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1981 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/03/1982 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/28/1980 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 12/01/1978 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/19/1978 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/04/1977 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 06/29/1976 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/24/1974 | SUPPL-1 | Manufacturing (CMC)-Control |
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-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf | |
| 06/10/2002 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf | |
| 06/10/2002 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf |
RETIN-A
CREAM;TOPICAL; 0.05%
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RETIN-A | TRETINOIN | 0.05% | CREAM;TOPICAL | Prescription | Yes | AB1 | 017522 | VALEANT BERMUDA |
| TRETINOIN | TRETINOIN | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 075265 | PADAGIS US |
| TRETINOIN | TRETINOIN | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 211644 | TARO |