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- Topiramate TOPIRAMATE 100 mg/1 Zydus Lifesciences Limited
Topiramate
- TOPIRAMATE TOPIRAMATE 100 mg/1 Glenmark Pharmaceuticals Inc., USA
- QUDEXY XR TOPIRAMATE 100 mg/1 Upsher-Smith Laboratories, LLC
- Topiramate TOPIRAMATE 100 mg/1 Ajanta Pharma USA Inc.
- Topiramate TOPIRAMATE 100 mg/1 Zydus Lifesciences Limited
- Topiramate TOPIRAMATE 100 mg/1 Upsher-Smith Laboratories, LLC
- Topiramate TOPIRAMATE 100 mg/1 Par Pharmaceutical, Inc.
- Topiramate TOPIRAMATE 100 mg/1 Teva Pharmaceuticals, Inc.
- TOPIRAMATE TOPIRAMATE 100 mg/1 NorthStar RxLLC
- Topiramate TOPIRAMATE 100 mg/1 Zydus Pharmaceuticals USA Inc.
- TOPIRAMATE TOPIRAMATE 100 mg/1 NorthStar RxLLC
- Topiramate TOPIRAMATE 100 mg/1 Zydus Lifesciences Limited
- Topiramate TOPIRAMATE 100 mg/1 Zydus Pharmaceuticals USA Inc.
- QUDEXY XR TOPIRAMATE 100 mg/1 Upsher-Smith Laboratories, LLC
Summary of product characteristics
Effective Time
20230928
Version
3
Spl Product Data Elements
Topiramate Topiramate TOPIRAMATE TOPIRAMATE ETHYLCELLULOSE (10 MPA.S) ETHYLCELLULOSE (45 MPA.S) FERRIC OXIDE RED FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSE 2910 (15 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER FLESH OPAQUE CAP WHITE OPAQUE BODY CAPSULE 1039 Topiramate Topiramate TOPIRAMATE TOPIRAMATE ETHYLCELLULOSE (10 MPA.S) ETHYLCELLULOSE (45 MPA.S) FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSE 2910 (15 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER IVORY OPAQUE CAP WHITE OPAQUE BODY CAPSULE 1040 Topiramate Topiramate TOPIRAMATE TOPIRAMATE ETHYLCELLULOSE (10 MPA.S) ETHYLCELLULOSE (45 MPA.S) FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSE 2910 (15 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER MEDIUM ORANGE OPAQUE CAP WHITE OPAQUE BODY CAPSULE 1041 Topiramate Topiramate TOPIRAMATE TOPIRAMATE ETHYLCELLULOSE (10 MPA.S) ETHYLCELLULOSE (45 MPA.S) FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSE 2910 (15 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER WHITE OPAQUE CAP WHITE OPAQUE BODY CAPSULE 1042 Topiramate Topiramate TOPIRAMATE TOPIRAMATE ETHYLCELLULOSE (10 MPA.S) ETHYLCELLULOSE (45 MPA.S) FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSE 2910 (15 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER LIGHT GREEN OPAQUE CAP WHITE OPAQUE BODY CAPSULE 1043
Application Number
ANDA208949
Brand Name
Topiramate
Generic Name
Topiramate
Product Ndc
70771-1658
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1656-3 Topiramate extended-release Capsules 25 mg Rx only 30 Capsules NDC 70771-1657-3 Topiramate extended-release Capsules 50 mg Rx only 30 Capsules NDC 70771-1658-3 Topiramate extended-release Capsules 100 mg Rx only 30 Capsules NDC 70771-1659-3 Topiramate extended-release Capsules 150 mg Rx only 30 Capsules NDC 70771-1660-3 Topiramate extended-release Capsules 200 mg Rx only 30 Capsules 25 mg label 50 mg label 100 mg label 150 mg label 200 mg label
Spl Medguide
SPL MEDGUIDE
Drug section
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