MedPath
FDA Product

Levetiracetam Extended Release

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Levetiracetam Extended Release

75834-246

Regulatory Information

75834-246

ANDA201464

C73584

June 14, 2023

USA

These highlights do not include all the information needed to use LEVETIRACETAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM EXTENDED-RELEASE TABLETS. LEVETIRACETAM Extended-Release Tablets, for oral use Initial U.S. Approval: 1999

Human Prescription Drug Label

2

Company Information

052032418

Active Ingredients

LEVETIRACETAM

Quantity: 750 mg in 1 1

Code: 44YRR34555

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

ETHYLCELLULOSE, UNSPECIFIED

Code: 7Z8S9VYZ4B

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

Active Moieties

LEVETIRACETAM

Code: 44YRR34555

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