Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205069
Company: MYLAN

Products on ANDA 205069

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205069

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/22/2018	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.
03/18/2022	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205069

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

TABLET;ORAL-28; 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CHABELINA FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG	TABLET;ORAL-28	Prescription	No	AB	202962	NOVAST LABS
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG	TABLET;ORAL-28	Prescription	No	AB	205069	MYLAN
TRI-LEGEST FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG,0.03MG,0.035MG;1MG,1MG,1MG	TABLET;ORAL-28	Prescription	No	AB	076105	BARR