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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204426
Company: APIL

Summary Review

Products on NDA 204426

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TAYTULLA	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204426

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/19/2013	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/2013/204426s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204426Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204426_minastrin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204426Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204426s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204426Orig1s010ltr.pdf
06/26/2023	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204426s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204426Orig1s009ltr.pdf
08/09/2017	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204426s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204426Orig1s007ltr.pdf
08/19/2016	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204426s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204426Orig1s004ltr.pdf
07/22/2015	SUPPL-1	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204426s001lbl.pdf

Labels for NDA 204426

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/26/2023	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204426s009lbl.pdf
04/29/2022	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204426s010lbl.pdf
04/29/2022	SUPPL-10	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204426s010lbl.pdf
08/09/2017	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204426s007lbl.pdf
08/19/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204426s004lbl.pdf
07/22/2015	SUPPL-1	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204426s001lbl.pdf
04/19/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204426s000lbl.pdf

Therapeutic Equivalents for NDA 204426

TAYTULLA

CAPSULE;ORAL; 0.02MG;1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GEMMILY	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	CAPSULE;ORAL	Prescription	No	AB	213317	XIROMED
MERZEE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	CAPSULE;ORAL	Prescription	No	AB	212706	WILSHIRE PHARMS INC
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	CAPSULE;ORAL	Prescription	No	AB	213418	GLENMARK PHARMS LTD
TAYTULLA	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	CAPSULE;ORAL	Prescription	Yes	AB	204426	APIL

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