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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074511
Company: EPIC PHARMA LLC

Products on ANDA 074511

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SULSTER	PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM	EQ 0.23% PHOSPHATE;10%	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074511

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/1996	ORIG-1	Approval			Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/96/074511_sulster_toc.cfm

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