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- Topiramate TOPIRAMATE 200 mg/1 Zydus Lifesciences Limited
Topiramate
- QUDEXY XR TOPIRAMATE 200 mg/1 Upsher-Smith Laboratories, LLC
- TOPIRAMATE TOPIRAMATE 200 mg/1 NorthStar RxLLC
- TOPIRAMATE TOPIRAMATE 200 mg/1 NorthStar RxLLC
- Topiramate TOPIRAMATE 200 mg/1 Par Pharmaceutical, Inc.
- Topiramate TOPIRAMATE 200 mg/1 Zydus Pharmaceuticals USA Inc.
- Topiramate TOPIRAMATE 200 mg/1 Zydus Lifesciences Limited
- TOPIRAMATE TOPIRAMATE 200 mg/1 Glenmark Pharmaceuticals Inc., USA
- Topiramate TOPIRAMATE 200 mg/1 Upsher-Smith Laboratories, LLC
- QUDEXY XR TOPIRAMATE 200 mg/1 Upsher-Smith Laboratories, LLC
- Topiramate TOPIRAMATE 200 mg/1 Zydus Pharmaceuticals USA Inc.
- Topiramate TOPIRAMATE 200 mg/1 Teva Pharmaceuticals, Inc.
- Topiramate TOPIRAMATE 200 mg/1 Ajanta Pharma USA Inc.
- Topiramate TOPIRAMATE 200 mg/1 Zydus Lifesciences Limited
- Topiramate TOPIRAMATE 200 mg/1 Teva Pharmaceuticals, Inc.
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
70771-1858
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
Drug section
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