Drugs@FDA: FDA-Approved Drugs
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RETIN-A | TRETINOIN | 0.025% | 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 |
---|---|---|---|---|---|---|---|
09/16/1988 | 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-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/08/2013 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/06/2002 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/20/2001 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
06/10/2002 | SUPPL-11 | 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-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/23/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/10/2002 | SUPPL-8 | 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-7 | 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-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/03/1990 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/28/1990 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
08/28/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
12/01/1989 | SUPPL-1 | Manufacturing (CMC)-Packaging |
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-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf | |
06/10/2002 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf | |
06/10/2002 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf |
RETIN-A
CREAM;TOPICAL; 0.025%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AVITA | TRETINOIN | 0.025% | CREAM;TOPICAL | Prescription | No | AB | 020404 | MYLAN PHARMS INC |
RETIN-A | TRETINOIN | 0.025% | CREAM;TOPICAL | Prescription | Yes | AB | 019049 | BAUSCH |
TRETINOIN | TRETINOIN | 0.025% | CREAM;TOPICAL | Prescription | No | AB | 075264 | PADAGIS US |
TRETINOIN | TRETINOIN | 0.025% | CREAM;TOPICAL | Prescription | No | AB | 215713 | TARO |