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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072695
Company: BARR

Products on ANDA 072695

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORTREL 0.5/35-28	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.5MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072695

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/1992	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-30	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/10/2022	SUPPL-26	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
02/10/2022	SUPPL-25	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/10/2022	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
02/27/2013	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
12/04/2001	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
12/04/2001	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
12/11/2002	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
08/22/2001	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
03/13/2001	SUPPL-7	Labeling		Label is not available on this site.
12/21/1999	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
03/07/2001	SUPPL-5	Labeling		Label is not available on this site.
03/07/2001	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/07/2001	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/07/2001	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/07/2001	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 072695

NORTREL 0.5/35-28

TABLET;ORAL-28; 0.035MG;0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYONANZ	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.5MG	TABLET;ORAL-28	Prescription	No	AB	207055	AUROBINDO PHARMA
NORTREL 0.5/35-28	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.5MG	TABLET;ORAL-28	Prescription	No	AB	072695	BARR
WERA	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.5MG	TABLET;ORAL-28	Prescription	No	AB	091204	NOVAST LABS LTD

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