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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076381
Company: BARR

Products on ANDA 076381

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
JUNEL 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 076381

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/30/2003	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
09/25/2023	SUPPL-26	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/25/2023	SUPPL-23	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/18/2021	SUPPL-18	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
10/20/2004	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076381

JUNEL 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 SPECLT
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	XIROMED

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