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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090950
Company: SANDOZ

Products on ANDA 090950

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPINASTINE HYDROCHLORIDE	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION; OPHTHALMIC	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090950

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2011	ORIG-1	Tentative Approval				Label is not available on this site.

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