Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076238
Company: BARR

Products on ANDA 076238

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BALZIVA-28	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.4MG	TABLET;ORAL-28	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076238

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/22/2004	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
04/29/2022	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
08/09/2017	SUPPL-20	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076238

BALZIVA-28

TABLET;ORAL-28; 0.035MG;0.4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BALZIVA-28	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.4MG	TABLET;ORAL-28	Prescription	No	AB	076238	BARR
BRIELLYN	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.4MG	TABLET;ORAL-28	Prescription	No	AB	090538	GLENMARK PHARMS LTD
GILDAGIA	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.4MG	TABLET;ORAL-28	Prescription	No	AB	078376	VINTAGE PHARMS
NORETHINDRONE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.4MG	TABLET;ORAL-28	Prescription	No	AB	078323	WATSON LABS
PHILITH	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.4MG	TABLET;ORAL-28	Prescription	No	AB	090947	NOVAST LABS LTD
VYFEMLA	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.4MG	TABLET;ORAL-28	Prescription	No	AB	201886	LUPIN LTD