Application 040298

Type: ANDA
Sponsor: MYLAN

Related Records

Company: MYLAN

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EXTENDED PHENYTOIN SODIUM	PHENYTOIN SODIUM	CAPSULE;ORAL	100MG EXTENDED	No	No
002	PHENYTEK	PHENYTOIN SODIUM	CAPSULE;ORAL	200MG EXTENDED	No	No
003	PHENYTEK	PHENYTOIN SODIUM	CAPSULE;ORAL	300MG EXTENDED	No	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-1560	Phenytoin Sodium	phenytoin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1560	Phenytoin Sodium	phenytoin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1560	Phenytoin Sodium	phenytoin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1560	Phenytoin Sodium	phenytoin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1560	Phenytoin Sodium	phenytoin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1560	Phenytoin Sodium	phenytoin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2670	Phenytek	extended phenytoin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2670	Phenytek	extended phenytoin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2670	Phenytek	extended phenytoin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2670	Phenytek	extended phenytoin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2670	Phenytek	extended phenytoin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2670	Phenytek	extended phenytoin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3750	Phenytek	phenytoin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3750	Phenytek	phenytoin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3750	Phenytek	phenytoin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3750	Phenytek	phenytoin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3750	Phenytek	phenytoin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3750	Phenytek	phenytoin sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-1343	Phenytoin Sodium	phenytoin sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
51079-905	Phenytoin Sodium	phenytoin sodium	Mylan Institutional Inc.	ANDA	Current
51079-905	Phenytoin Sodium	phenytoin sodium	Mylan Institutional Inc.	ANDA	Current
51079-905	Phenytoin Sodium	phenytoin sodium	Mylan Institutional Inc.	ANDA	Current
51079-905	Phenytoin Sodium	phenytoin sodium	Mylan Institutional Inc.	ANDA	Current
53808-0652	Phenytoin Sodium	phenytoin sodium	State of Florida DOH Central Pharmacy	ANDA	Current
55154-5496	Phenytoin Sodium	phenytoin sodium	Cardinal Health	ANDA	Current
55154-5496	Phenytoin Sodium	phenytoin sodium	Cardinal Health	ANDA	Current
63629-2552	Phenytoin Sodium	phenytoin sodium	Bryant Ranch Prepack	ANDA	Current
67544-517	Phenytoin Sodium	phenytoin sodium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-517	Phenytoin Sodium	phenytoin sodium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents

Document	Submission type	Date
22119	ORIG	2003-12-23
29919	SUPPL	2003-04-08
29918	SUPPL	2003-04-08
7611	SUPPL	2003-04-08
17764	ORIG	1998-12-28
7610	ORIG	1998-12-28