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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205131
Company: XIROMED

Products on ANDA 205131

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	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 205131

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/2017	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
03/30/2023	SUPPL-5	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
03/30/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
08/30/2018	SUPPL-1	Labeling-Proprietary Name Change		Label is not available on this site.

Therapeutic Equivalents for ANDA 205131

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

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	MYLAN LABS LTD
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

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