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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020438
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VESANOID TRETINOIN 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No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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