Application 103575

Type: BLA
Sponsor: CENTOCOR INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REOPRO	ABCIXIMAB	INJECTABLE; INJECTION	2MG/ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57894-200	REOPRO	abciximab	Janssen Biotech, Inc.	BLA	Current
57894-200	REOPRO	abciximab	Janssen Biotech, Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59650	SUPPL	2019-08-09
59649	SUPPL	2019-08-09
59629	SUPPL	2019-08-08
9398	SUPPL	2013-11-27
39659	SUPPL	2013-11-26
43270	SUPPL	2004-03-29
31594	SUPPL	2004-03-29
22737	SUPPL	2004-03-29
18589	SUPPL	2004-03-29
18588	SUPPL	2004-03-29
9396	SUPPL	2004-03-29
31595	SUPPL	2003-12-04
9397	SUPPL	2003-12-04