Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206201
Company: MAYNE PHARMA INC

Products on ANDA 206201

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ETHINYL ESTRADIOL; LEVONORGESTREL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206201

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	Tentative Approval		STANDARD		Label is not available on this site.