Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050554
Company: BRISTOL

Products on NDA 050554

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRECEF	CEFORANIDE	500MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
PRECEF	CEFORANIDE	1GM/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
PRECEF	CEFORANIDE	2GM/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
PRECEF	CEFORANIDE	10GM/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
PRECEF	CEFORANIDE	20GM/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050554

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/24/1984	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.