Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020438
Company: CHEPLAPHARM
Company: CHEPLAPHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VESANOID | TRETINOIN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/22/1995 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/01/2008 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020438s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020438s006ltr.pdf | |
| 10/05/2004 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20438s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20438s004ltr.pdf | |
| 02/14/2000 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020438-S001_VESANOID_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/020438-S001_VESANOID_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20438-S001_VESANOID_review.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/01/2008 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020438s006lbl.pdf | |
| 10/05/2004 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20438s004lbl.pdf | |
| 02/14/2000 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020438-S001_VESANOID_lbl.pdf |
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