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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021871
Company: TEVA BRANDED PHARM

Products on NDA 021871

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOESTRIN 24 FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No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 021871

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/17/2006	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021871lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021871s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021871TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/04/2023	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021871s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021871Orig1s013ltr.pdf
04/29/2022	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021871s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021871Orig1s012ltr.pdf
09/02/2021	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021871s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021871Orig1s010ltr.pdf
08/09/2017	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021871s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021871Orig1s008ltr.pdf
04/19/2016	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/01/2013	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/10/2010	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
08/22/2016	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021871s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021871Orig1s001ltr.pdf

Labels for NDA 021871

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/04/2023	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021871s013lbl.pdf
04/29/2022	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021871s012lbl.pdf
09/02/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021871s010lbl.pdf
08/09/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021871s008lbl.pdf
08/22/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021871s001lbl.pdf
02/17/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021871lbl.pdf

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