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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020438
Company: CHEPLAPHARM

Products on NDA 020438

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VESANOID	TRETINOIN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020438

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
10/04/2024	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020438s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020438Orig1s009ltr.pdf
02/21/2023	SUPPL-8	Efficacy-Manufacturing Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020438s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020438Orig1s007;s008ltr.pdf
02/21/2023	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020438s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020438Orig1s007;s008ltr.pdf
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

Labels for NDA 020438

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/04/2024	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020438s009lbl.pdf
02/21/2023	SUPPL-8	Efficacy-Manufacturing Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020438s007s008lbl.pdf
02/21/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020438s007s008lbl.pdf
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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