Application 090253

Type: ANDA
Sponsor: ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	CAPSULE;ORAL	250MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7074	mycophenolate mofetil	mycophenolate mofetil	Major Pharmaceuticals	ANDA	Current
0904-7074	mycophenolate mofetil	mycophenolate mofetil	Major Pharmaceuticals	ANDA	Current
16729-094	mycophenolate mofetil	mycophenolate mofetil	Accord Healthcare Inc.	ANDA	Current
16729-094	mycophenolate mofetil	mycophenolate mofetil	Accord Healthcare Inc.	ANDA	Current
16729-094	mycophenolate mofetil	mycophenolate mofetil	Accord Healthcare Inc.	ANDA	Current
16729-094	mycophenolate mofetil	mycophenolate mofetil	Accord Healthcare Inc.	ANDA	Current
70518-2835	mycophenolate mofetil	mycophenolate mofetil	REMEDYREPACK INC.	ANDA	Current
70518-2835	mycophenolate mofetil	mycophenolate mofetil	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44548	ORIG	2015-07-02
44417	ORIG	2009-07-15