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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020683
Company: CADENCE HEALTH

Products on NDA 020683

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALESSE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL-21	Discontinued	None	Yes	No
ALESSE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL-28	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020683

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/27/1997	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020683_alesse_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020683s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020683Orig1s016ltr.pdf
03/20/2018	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020683s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020683Orig1s012ltr.pdf
08/09/2017	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020683s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020683Orig1s011ltr.pdf
01/31/2008	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020683s007ltr.pdf
01/31/2008	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020683s006ltr.pdf
03/06/2002	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
01/31/2008	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020683s004ltr.pdf
02/12/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020683

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020683s016lbl.pdf
03/20/2018	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020683s012lbl.pdf
08/09/2017	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020683s011lbl.pdf
01/31/2008	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf
01/31/2008	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf
01/31/2008	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020683s004s006s007lbl.pdf

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