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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201536
Company: APOTEX INC

Products on ANDA 201536

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELETRIPTAN HYDROBROMIDE	ELETRIPTAN HYDROBROMIDE	20MG	TABLET; ORAL	None (Tentative Approval)	None	No	No
ELETRIPTAN HYDROBROMIDE	ELETRIPTAN HYDROBROMIDE	40MG	TABLET; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201536

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/2013	ORIG-1	Tentative Approval				Label is not available on this site.

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