Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203604
Company: HI-TECH PHARMACAL

Products on ANDA 203604

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BIMATOPROST	BIMATOPROST	UNKNOWN	UNKNOWN	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203604

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/2019	ORIG-1	Tentative Approval				Label is not available on this site.