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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204847
Company: GLENMARK PHARMS LTD

Products on ANDA 204847

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204847

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/07/2023	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/07/2023	SUPPL-6	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
04/29/2022	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/07/2022	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204847

HAILEY 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
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	PH HEALTH
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
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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