Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019963
Company: VALEANT PHARMS NORTH
Company: VALEANT PHARMS NORTH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RENOVA | TRETINOIN | 0.05% | CREAM;TOPICAL | Prescription | AB2 | 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 |
---|---|---|---|---|---|---|---|
12/29/1995 | 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 |
---|---|---|---|---|---|
01/08/2013 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/20/2001 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/01/2000 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19963S5,7LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19963S5,7LTR.PDF | |
01/25/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/01/2000 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19963S5,7LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19963S5,7LTR.PDF | |
07/23/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/20/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
08/19/1996 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/09/1996 | 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 |
---|---|---|---|---|---|
08/01/2000 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19963S5,7LBL.PDF | |
08/01/2000 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19963S5,7LBL.PDF |
RENOVA
CREAM;TOPICAL; 0.05%
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RENOVA | TRETINOIN | 0.05% | CREAM;TOPICAL | Prescription | Yes | AB2 | 019963 | VALEANT PHARMS NORTH |
TRETINOIN | TRETINOIN | 0.05% | CREAM;TOPICAL | Prescription | No | AB2 | 076498 | ZO SKIN HEALTH |
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