Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209297
Company: GLENMARK PHARMS

Products on ANDA 209297

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HAILEY 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET;ORAL-21	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209297

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/2018	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
08/23/2023	SUPPL-4	Labeling-Patient Package Insert		Label is not available on this site.
08/23/2023	SUPPL-3	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209297

HAILEY 1.5/30

TABLET;ORAL-21; 0.03MG;1.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AUROVELA 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET;ORAL-21	Prescription	No	AB	207581	AUROBINDO PHARMA
HAILEY 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET;ORAL-21	Prescription	No	AB	209297	GLENMARK PHARMS
JUNEL 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET;ORAL-21	Prescription	No	AB	076381	BARR
LARIN 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET;ORAL-21	Prescription	No	AB	202996	NOVAST LABS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET;ORAL-21	Prescription	No	AB	202770	MYLAN LABS LTD