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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022262
Company: TEVA BRANDED PHARM

Summary Review

Products on NDA 022262

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOSEASONIQUE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.1MG;0.01MG,N/A	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022262

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/24/2008	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022262lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022262s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022262_loseasonique_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022262s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022262s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022262Orig1s006ltr.pdf
01/27/2023	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022262s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022262Orig1s003,s004ltr.pdf
01/27/2023	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022262s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022262Orig1s003,s004ltr.pdf
08/09/2017	SUPPL-2	Labeling-Package Insert	Label (PDF) Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022262s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022262Orig1s002ltr.pdf
04/07/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022262

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/27/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022262s003s004lbl.pdf
01/27/2023	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022262s003s004lbl.pdf
04/29/2022	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022262s006lbl.pdf
08/09/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022262s002lbl.pdf
08/09/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022262Orig1s002ltr.pdf
10/24/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022262lbl.pdf

Therapeutic Equivalents for NDA 022262

LOSEASONIQUE

TABLET;ORAL; 0.02MG,0.1MG;0.01MG,N/A
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.1MG;0.01MG,N/A	TABLET;ORAL	Prescription	No	AB	091674	LUPIN LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.1MG;0.01MG,N/A	TABLET;ORAL	Prescription	No	AB	200493	XIROMED
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.1MG;0.01MG,N/A	TABLET;ORAL	Prescription	No	AB	205131	XIROMED
LO SIMPESSE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.1MG;0.01MG,N/A	TABLET;ORAL	Prescription	No	AB	206852	AUROBINDO PHARMA
LOSEASONIQUE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.1MG;0.01MG,N/A	TABLET;ORAL	Prescription	No	AB	022262	TEVA BRANDED PHARM

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