Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206852
Company: AUROBINDO PHARMA

Products on ANDA 206852

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LO SIMPESSE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.1MG;0.01MG,N/A	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206852

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2017	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
06/20/2025	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206852

LO SIMPESSE

TABLET;ORAL; 0.02MG,0.1MG;0.01MG,N/A
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.1MG;0.01MG,N/A	TABLET;ORAL	Prescription	No	AB	091674	LUPIN LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.1MG;0.01MG,N/A	TABLET;ORAL	Prescription	No	AB	200493	XIROMED
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.1MG;0.01MG,N/A	TABLET;ORAL	Prescription	No	AB	205131	XIROMED
LO SIMPESSE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.1MG;0.01MG,N/A	TABLET;ORAL	Prescription	No	AB	206852	AUROBINDO PHARMA
LOSEASONIQUE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.1MG;0.01MG,N/A	TABLET;ORAL	Prescription	No	AB	022262	TEVA BRANDED PHARM