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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206287
Company: LUPIN

Products on ANDA 206287

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIBELAS 24 FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206287

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/24/2016	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206287Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/22/2023	SUPPL-18	Labeling-Patient Package Insert		Label is not available on this site.
09/09/2019	SUPPL-8	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Patient Package Insert		Label is not available on this site.
09/09/2019	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/09/2019	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206287

MIBELAS 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	ENDO OPERATIONS
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
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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