Phenytek - 0378-3750-93 - (phenytoin sodium)

Alphabetical Index


Drug Information of Phenytek

Product NDC: 0378-3750
Proprietary Name: Phenytek
Non Proprietary Name: phenytoin sodium
Active Ingredient(s): 300    mg/1 & nbsp;   phenytoin sodium
Administration Route(s): ORAL
Dosage Form(s): CAPSULE, EXTENDED RELEASE
Coding System: National Drug Codes(NDC)

Labeler Information of Phenytek

Product NDC: 0378-3750
Labeler Name: Mylan Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA040298
Marketing Category: ANDA
Start Marketing Date: 20110707

Package Information of Phenytek

Package NDC: 0378-3750-93
Package Description: 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-3750-93)

NDC Information of Phenytek

NDC Code 0378-3750-93
Proprietary Name Phenytek
Package Description 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-3750-93)
Product NDC 0378-3750
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name phenytoin sodium
Dosage Form Name CAPSULE, EXTENDED RELEASE
Route Name ORAL
Start Marketing Date 20110707
Marketing Category Name ANDA
Labeler Name Mylan Pharmaceuticals Inc.
Substance Name PHENYTOIN SODIUM
Strength Number 300
Strength Unit mg/1
Pharmaceutical Classes Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

Complete Information of Phenytek


General Information