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FDA Drug information

Topiramate

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20231108

Version

6

Spl Product Data Elements

Topiramate Topiramate TOPIRAMATE TOPIRAMATE CELLULOSE, MICROCRYSTALLINE ETHYLCELLULOSE, UNSPECIFIED FERROSOFERRIC OXIDE GELATIN HYDROGENATED CASTOR OIL HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM HYDROXIDE POVIDONE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER WHITE OPAQUE WHITE OPAQUE 863 Topiramate Topiramate TOPIRAMATE TOPIRAMATE ETHYLCELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED HYDROGENATED CASTOR OIL CELLULOSE, MICROCRYSTALLINE POVIDONE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TRIETHYL CITRATE GELATIN SODIUM LAURYL SULFATE TITANIUM DIOXIDE FERROSOFERRIC OXIDE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC WATER WHITE OPAQUE WHITE OPAQUE 864 Topiramate Topiramate TOPIRAMATE TOPIRAMATE ALCOHOL AMMONIA BUTYL ALCOHOL CELLULOSE, MICROCRYSTALLINE ETHYLCELLULOSE, UNSPECIFIED FERROSOFERRIC OXIDE GELATIN HYDROGENATED CASTOR OIL HYPROMELLOSE, UNSPECIFIED ISOPROPYL ALCOHOL POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM HYDROXIDE POVIDONE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER WHITE OPAQUE WHITE OPAQUE 769 Topiramate Topiramate TOPIRAMATE TOPIRAMATE CELLULOSE, MICROCRYSTALLINE ETHYLCELLULOSE, UNSPECIFIED FERROSOFERRIC OXIDE GELATIN HYDROXYPROPYL CELLULOSE (90000 WAMW) HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER WHITE OPAQUE WHITE OPAQUE 358

Application Number

ANDA207382

Brand Name

Topiramate

Generic Name

Topiramate

Product Ndc

70771-1316

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1315-3 Topiramate extended-release capsules, 25 mg 30 capsules Rx only NDC 70771-1316-3 Topiramate extended-release capsules, 50 mg 30 capsules Rx only NDC 70771-1317-3 Topiramate extended-release capsules, 100 mg 30 capsules Rx only NDC 70771-1858-3 Topiramate extended-release capsules, 200 mg 30 capsules Rx only 25 mg 50 mg 100 mg 200 mg

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