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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204061
Company: TEVA BRANDED PHARM

Summary Review

Products on NDA 204061

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QUARTETTE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204061

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/28/2013	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/2013/204061s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204061Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204061_quartette_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204061Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204061s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204061Orig1s008ltr.pdf
08/04/2022	SUPPL-6	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204061s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204061Orig1s005, s006ltr.pdf
08/04/2022	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204061s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204061Orig1s005, s006ltr.pdf
08/09/2017	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204061s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204061Orig1s002ltr.pdf

Labels for NDA 204061

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/04/2022	SUPPL-6	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204061s005s006lbl.pdf
08/04/2022	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204061s005s006lbl.pdf
08/04/2022	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204061s005s006lbl.pdf
04/29/2022	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204061s008lbl.pdf
04/29/2022	SUPPL-8	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204061s008lbl.pdf
08/09/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204061s002lbl.pdf
03/28/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204061s000lbl.pdf

Therapeutic Equivalents for NDA 204061

QUARTETTE

TABLET;ORAL; 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;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,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET;ORAL	Prescription	No	AB	206053	XIROMED
QUARTETTE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET;ORAL	Prescription	Yes	AB	204061	TEVA BRANDED PHARM

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