Clinical Trials

Find trials by condition, location & phase

Drug Monographs

Browse drug monographs and information

Explore organizations and their profiles

Latest updates on trials and healthcare

Approved products by global authorities

AI-Powered Research

Discover powerful insights with advanced AI analysis tools for clinical trials.

Premium Access

Get unlimited access to our comprehensive pharmaceutical database and analytics.

FDA Approval

Phenytek

CompanyMylan Pharmaceuticals Inc. (DUNS: 059295980)

Effective Date

August 29, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Phenytoin(200 mg in 1 1)

Products (2)

Phenytek

NDC Product Code

0378-2670

Application Number

ANDA040298

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 16, 2023

Ingredients

PhenytoinActive

Code: 4182431BJHClass: ACTIBQuantity: 200 mg in 1 1

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive

Code: S38J6RZN16Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

FD&C BLUE NO. 1--ALUMINUM LAKEInactive

Code: J9EQA3S2JMClass: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

MAGNESIUM OXIDEInactive

Code: 3A3U0GI71GClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693YClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

Phenytek

NDC Product Code

0378-3750

Application Number

ANDA040298

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 16, 2023

Ingredients

MAGNESIUM OXIDEInactive

Code: 3A3U0GI71GClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

MICROCRYSTALLINE CELLULOSE 102Inactive

Code: PNR0YF693YClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

PhenytoinActive

Code: 4182431BJHClass: ACTIBQuantity: 300 mg in 1 1

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive

Code: S38J6RZN16Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FD&C BLUE NO. 1--ALUMINUM LAKEInactive

Code: J9EQA3S2JMClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy