Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207506
Company: AUROBINDO PHARMA

Products on ANDA 207506

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AUROVELA 1/20	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL-21	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207506

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/16/2017	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
03/28/2024	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/28/2024	SUPPL-6	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
03/28/2024	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207506

AUROVELA 1/20

TABLET;ORAL-21; 0.02MG;1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AUROVELA 1/20	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL-21	Prescription	No	AB	207506	AUROBINDO PHARMA
JUNEL 1/20	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL-21	Prescription	No	AB	076380	BARR
LARIN 1/20	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL-21	Prescription	No	AB	202995	NOVAST LABS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL-21	Prescription	No	AB	206969	GLENMARK PHARMS LTD
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL-21	Prescription	No	AB	202771	MYLAN LABS LTD