Application 200197

Type: ANDA
Sponsor: ALKEM LABS LTD

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
67877-266	mycophenolate mofetil	mycophenolate mofetil	Ascend Laboratories, LLC	ANDA	Current
67877-266	mycophenolate mofetil	mycophenolate mofetil	Ascend Laboratories, LLC	ANDA	Current
67877-266	mycophenolate mofetil	mycophenolate mofetil	Ascend Laboratories, LLC	ANDA	Current
67877-266	mycophenolate mofetil	mycophenolate mofetil	Ascend Laboratories, LLC	ANDA	Current
67877-266	mycophenolate mofetil	mycophenolate mofetil	Ascend Laboratories, LLC	ANDA	Current
67877-266	mycophenolate mofetil	mycophenolate mofetil	Ascend Laboratories, LLC	ANDA	Current
70518-3068	mycophenolate mofetil	mycophenolate mofetil	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44569	ORIG	2015-07-02