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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016921
Company: VALEANT INTL

Products on NDA 016921

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RETIN-A	TRETINOIN	0.05%	SOLUTION;TOPICAL	Discontinued	None	Yes	No
RETIN-A	TRETINOIN	0.05%	SWAB;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016921

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/20/1971	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2002	SUPPL-25	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-24	Manufacturing (CMC)		Label is not available on this site.
07/23/1998	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
06/10/2002	SUPPL-22	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-21	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-20	Manufacturing (CMC)-Control		Label is not available on this site.
08/28/1990	SUPPL-19	Labeling		Label is not available on this site.
07/22/1986	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
06/06/1983	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
07/28/1981	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
12/13/1982	SUPPL-14	Labeling		Label is not available on this site.
04/28/1980	SUPPL-13	Labeling		Label is not available on this site.
10/24/1979	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
12/04/1978	SUPPL-11	Labeling		Label is not available on this site.
01/04/1977	SUPPL-10	Labeling		Label is not available on this site.
09/20/1974	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 016921

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2002	SUPPL-25	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
06/10/2002	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf
06/10/2002	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf

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