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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091690
Company: NOVAST LABS

Products on ANDA 091690

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091690

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/2015	ORIG-1	Tentative Approval				Label is not available on this site.

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