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): 076081
Company: BARR

Products on ANDA 076081

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
JUNEL FE 1/20	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076081

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/18/2003	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-30	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/25/2023	SUPPL-27	Labeling-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-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076081

JUNEL FE 1/20

TABLET;ORAL-28; 0.02MG;1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AUROVELA FE 1/20	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL-28	Prescription	No	AB	207505	AUROBINDO PHARMA
BLISOVI FE 1/20	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL-28	Prescription	No	AB	201584	LUPIN LTD
HAILEY FE 1/20	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL-28	Prescription	No	AB	206597	GLENMARK PHARMS LTD
JUNEL FE 1/20	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL-28	Prescription	No	AB	076081	BARR
LARIN FE 1/20	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL-28	Prescription	No	AB	091454	NOVAST LABS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL-28	Prescription	No	AB	202772	XIROMED

Top