Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076221
Company: BARR LABS INC

Products on ANDA 076221

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.005MG;1MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076221

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/06/2009	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/076221s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-15	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
01/29/2024	SUPPL-14	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
01/07/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076221

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

TABLET;ORAL; 0.005MG;1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FYAVOLV	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.005MG;1MG	TABLET;ORAL	Prescription	No	AB	204213	LUPIN LTD
LERIBANE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.005MG;1MG	TABLET;ORAL	Prescription	No	AB	203435	NOVAST LABS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.005MG;1MG	TABLET;ORAL	Prescription	No	AB	076221	BARR LABS INC
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.005MG;1MG	TABLET;ORAL	Prescription	No	AB	203038	GLENMARK PHARMS LTD