Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207055
Company: AUROBINDO PHARMA

Products on ANDA 207055

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYONANZ	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.5MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207055

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/21/2016	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
04/29/2022	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
02/10/2022	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207055

CYONANZ

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYONANZ	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.5MG	TABLET;ORAL-28	Prescription	No	AB	207055	AUROBINDO PHARMA
NORTREL 0.5/35-28	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.5MG	TABLET;ORAL-28	Prescription	No	AB	072695	BARR LABS
WERA	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;0.5MG	TABLET;ORAL-28	Prescription	No	AB	091204	NOVAST LABS LTD