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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206850
Company: AUROBINDO PHARMA LTD

Products on ANDA 206850

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206850

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2018	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
06/24/2024	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
06/24/2024	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
06/24/2024	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206850

ICLEVIA

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	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	203871	NAARI PTE
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG;0.15MG	TABLET;ORAL	Prescription	No	AB	200490	XIROMED
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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