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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203038
Company: GLENMARK PHARMS LTD

Products on ANDA 203038

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.0025MG;0.5MG	TABLET;ORAL	Prescription	AB	No	No
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.005MG;1MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203038

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/02/2015	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/16/2024	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
01/26/2024	SUPPL-6	Labeling-Patient Package Insert		Label is not available on this site.
01/13/2021	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203038

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

TABLET;ORAL; 0.0025MG;0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FYAVOLV	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.0025MG;0.5MG	TABLET;ORAL	Prescription	No	AB	204213	LUPIN LTD
LERIBANE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.0025MG;0.5MG	TABLET;ORAL	Prescription	No	AB	203435	NOVAST LABS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.0025MG;0.5MG	TABLET;ORAL	Prescription	No	AB	203038	GLENMARK PHARMS LTD

TABLET;ORAL; 0.005MG;1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FYAVOLV	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.005MG;1MG	TABLET;ORAL	Prescription	No	AB	204213	LUPIN LTD
LERIBANE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.005MG;1MG	TABLET;ORAL	Prescription	No	AB	203435	NOVAST LABS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.005MG;1MG	TABLET;ORAL	Prescription	No	AB	076221	BARR LABS INC
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.005MG;1MG	TABLET;ORAL	Prescription	No	AB	203038	GLENMARK PHARMS LTD

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