Application 065413

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	TABLET;ORAL	500MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0166	Mycophenolate Mofetil	Mycophenolate Mofetil	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0166	Mycophenolate Mofetil	Mycophenolate Mofetil	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0166	Mycophenolate Mofetil	Mycophenolate Mofetil	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0166	Mycophenolate Mofetil	Mycophenolate Mofetil	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0166	Mycophenolate Mofetil	Mycophenolate Mofetil	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0166	Mycophenolate Mofetil	Mycophenolate Mofetil	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0166	Mycophenolate Mofetil	Mycophenolate Mofetil	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0166	Mycophenolate Mofetil	Mycophenolate Mofetil	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0166	Mycophenolate Mofetil	Mycophenolate Mofetil	West-Ward Pharmaceuticals Corp	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24041	ORIG	2015-07-06
39425	ORIG	2008-11-20
44238	ORIG	2008-09-19
8399	ORIG	2008-08-04