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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200490
Company: MYLAN LABS LTD

Products on ANDA 200490

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG;0.15MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200490

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/21/2015	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/18/2023	SUPPL-13	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/18/2023	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
02/28/2019	SUPPL-4	Labeling-Proprietary Name Change		Label is not available on this site.
02/28/2019	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200490

LEVONORGESTREL AND ETHINYL ESTRADIOL

TABLET;ORAL; 0.03MG;0.15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ICLEVIA	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG;0.15MG	TABLET;ORAL	Prescription	No	AB	206850	AUROBINDO PHARMA LTD
INTROVALE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG;0.15MG	TABLET;ORAL	Prescription	No	AB	079064	XIROMED
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG;0.15MG	TABLET;ORAL	Prescription	No	AB	203871	AMNEAL PHARMS
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG;0.15MG	TABLET;ORAL	Prescription	No	AB	203164	GLENMARK PHARMS LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG;0.15MG	TABLET;ORAL	Prescription	No	AB	091440	LUPIN LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG;0.15MG	TABLET;ORAL	Prescription	No	AB	200490	MYLAN LABS LTD
QUASENSE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG;0.15MG	TABLET;ORAL	Prescription	No	AB	077101	WATSON LABS
SEASONALE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG;0.15MG	TABLET;ORAL	Prescription	Yes	AB	021544	TEVA BRANDED PHARM
SETLAKIN	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG;0.15MG	TABLET;ORAL	Prescription	No	AB	090716	NOVAST LABS

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