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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203667
Company: APIL

Summary Review

Products on NDA 203667

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MINASTRIN 24 FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203667

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/08/2013	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/2013/203667s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203667Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203667_norethindrone_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203667Orig1s000SumR.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	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203667s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203667Orig1s014ltr.pdf
08/09/2017	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203667Orig1s009lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203667Orig1s009ltr.pdf
12/20/2016	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203667s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203667Orig1s007ltr.pdf
08/01/2016	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/03/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/05/2014	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203667s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203667Orig1s004ltr.pdf
04/14/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/11/2013	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203667s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203667Orig1s002ltr.pdf
11/19/2013	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203667

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203667s014lbl.pdf
08/09/2017	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203667Orig1s009lbledt.pdf
12/20/2016	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203667s007lbl.pdf
12/20/2016	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203667s007lbl.pdf
12/05/2014	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203667s004lbl.pdf
07/11/2013	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203667s002lbl.pdf
05/08/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203667s000lbl.pdf

Therapeutic Equivalents for NDA 203667

MINASTRIN 24 FE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AUROVELA 24 FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	207504	AUROBINDO PHARMA
BLISOVI 24 FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	091398	LUPIN LTD
FINZALA	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	210087	TEVA PHARMS USA INC
GILDESS 24 FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	090293	VINTAGE PHARMS
HAILEY 24 FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	204847	GLENMARK PHARMS LTD
LARIN 24 FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	202994	NOVAST LABS
MIBELAS 24 FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	206287	LUPIN
MINASTRIN 24 FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	Yes	AB	203667	APIL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	090938	BARR LABS INC
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	210369	GLENMARK PHARMS LTD
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	209609	XIROMED

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