Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 207580
Company: AUROBINDO PHARMA

Products on ANDA 207580

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AUROVELA FE 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207580

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/30/2023	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
10/30/2023	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
10/30/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207580

AUROVELA FE 1.5/30

TABLET;ORAL-28; 0.03MG;1.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AUROVELA FE 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET;ORAL-28	Prescription	No	AB	207580	AUROBINDO PHARMA
HAILEY FE 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET;ORAL-28	Prescription	No	AB	209031	GLENMARK PHARMS
JUNEL FE 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET;ORAL-28	Prescription	No	AB	076064	BARR
LARIN FE 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET;ORAL-28	Prescription	No	AB	091453	NOVAST LABS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET;ORAL-28	Prescription	No	AB	202741	MYLAN LABS LTD