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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022573
Company: TEVA BRANDED PHARM

Summary Review

Products on NDA 022573

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE	0.025MG;0.8MG	TABLET, CHEWABLE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022573

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2010	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022573s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022573s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022573_norethindrone_ethinyl_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022573Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-14	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022573s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022573Orig1s014ltr.pdf
06/26/2023	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022573s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022573Orig1s012ltr.pdf
08/09/2017	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022573s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022573Orig1s008ltr.pdf
08/12/2013	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/12/2013	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/13/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/11/2013	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022573

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/26/2023	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022573s012lbl.pdf
04/29/2022	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022573s014lbl.pdf
04/29/2022	SUPPL-14	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022573s014lbl.pdf
08/09/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022573s008lbl.pdf
12/22/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022573s000lbl.pdf

Therapeutic Equivalents for NDA 022573

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

TABLET, CHEWABLE;ORAL; 0.025MG;0.8MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KAITLIB FE	ETHINYL ESTRADIOL; NORETHINDRONE	0.025MG;0.8MG	TABLET, CHEWABLE;ORAL	Prescription	No	AB	203448	LUPIN LTD
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE	0.025MG;0.8MG	TABLET, CHEWABLE;ORAL	Prescription	Yes	AB	022573	TEVA BRANDED PHARM
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE	0.025MG;0.8MG	TABLET, CHEWABLE;ORAL	Prescription	No	AB	203371	XIROMED

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