Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079193
Company: BARR

Products on ANDA 079193

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079193

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/11/2010	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
07/11/2016	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 079193

ESTRADIOL AND NORETHINDRONE ACETATE

TABLET;ORAL; 1MG;0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACTIVELLA	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET;ORAL	Prescription	Yes	AB	020907	AMNEAL
ESTRADIOL AND NORETHINDRONE ACETATE	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET;ORAL	Prescription	No	AB	079193	BARR
ESTRADIOL AND NORETHINDRONE ACETATE	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET;ORAL	Prescription	No	AB	078324	BRECKENRIDGE PHARM
ESTRADIOL AND NORETHINDRONE ACETATE	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET;ORAL	Prescription	No	AB	207261	MYLAN LABS LTD
ESTRADIOL AND NORETHINDRONE ACETATE	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET;ORAL	Prescription	No	AB	210612	NOVAST LABS