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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021864
Company: WYETH PHARMS INC

Products on NDA 021864

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LYBREL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.09MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021864

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/22/2007	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021864lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021864s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021864_lybrel_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/16/2016	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021864s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021864Orig1s007ltr.pdf
12/31/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/15/2008	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021864s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021864s002ltr.pdf

Labels for NDA 021864

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/16/2016	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021864s007lbl.pdf
09/15/2008	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021864s002lbl.pdf
05/22/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021864lbl.pdf

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