An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075478
Company: BARR

Products on ANDA 075478

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORTREL 7/7/7	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET;ORAL-21	Prescription	None	No	No
NORTREL 7/7/7	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075478

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/30/2002	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75478TA.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-22	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/06/2020	SUPPL-18	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/26/2016	SUPPL-17	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
01/20/2015	SUPPL-15	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
12/31/2014	SUPPL-13	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/20/2004	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075478

NORTREL 7/7/7

TABLET;ORAL-28; 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALYACEN 7/7/7	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET;ORAL-28	Prescription	No	AB	091636	GLENMARK PHARMS LTD
DASETTA 7/7/7	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET;ORAL-28	Prescription	No	AB	090946	NOVAST LABS LTD
NORTREL 7/7/7	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET;ORAL-28	Prescription	No	AB	075478	BARR
NYLIA 7/7/7	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG	TABLET;ORAL-28	Prescription	No	AB	207054	AUROBINDO PHARMA

Top