TOPIRAMATE capsule, coated pellets

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)

可用日期:

Zydus Lifesciences Limited

INN（国际名称）:

TOPIRAMATE

组成:

TOPIRAMATE 15 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Topiramate tablets and topiramate capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. Topiramate tablets and topiramate capsules are indicated as adjunctive therapy for  for the treatment of partial-onset seizures,  primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older. Topiramate tablets and topiramate capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older. None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate during pregnancy. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-f

產品總結:

Topiramate Tablets, USP Topiramate Tablets USP, 25 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 16" on one side and plain on the other side and are supplied as follows: NDC 65841-647-14 in bottle of 60 tablets NDC 65841-647-16 in bottle of 90 tablets NDC 65841-647-01 in bottle of 100 tablets NDC 65841-647-05 in bottle of 500 tablets Topiramate Tablets USP, 50 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 15" on one side and plain on the other side and are supplied as follows: NDC 65841-648-14 in bottle of 60 tablets NDC 65841-648-16 in bottle of 90 tablets NDC 65841-648-01 in bottle of 100 tablets NDC 65841-648-05 in bottle of 500 tablets Topiramate Tablets USP, 100 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 14" on one side and plain on the other side and are supplied as follows: NDC 65841-649-14 in bottle of 60 tablets NDC 65841-649-16 in bottle of 90 tablets NDC 65841-649-01 in bottle of 100 tablets NDC 65841-649-05 in bottle of 500 tablets Topiramate Tablets USP, 200 mg are white to off-white, round-shaped, biconvex, beveled-edge, film-coated tablets debossed with "ZD 13" on one side and plain on the other side and are supplied as follows: NDC 65841-650-14 in bottle of 60 tablets NDC 65841-650-16 in bottle of 90 tablets NDC 65841-650-01 in bottle of 100 tablets NDC 65841-650-05 in bottle of 500 tablets Topiramate Capsules, USP Topiramate Capsules USP, 15 mg are white to off-white pellets filled in size '2' empty hard gelatin capsules with white opaque cap imprinted with "ZA63" and white opaque body imprinted with "15 mg" in black ink and are supplied as follows: NDC 65841-651-14 in bottle of 60 capsules NDC 65841-651-16 in bottle of 90 capsules NDC 65841-651-01 in bottle of 100 capsules NDC 65841-651-05 in bottle of 500 capsules NDC 65841-651-10 in bottle of 1000 capsules Topiramate Capsules USP, 25 mg are white to off-white pellets filled in size '1' empty hard gelatin capsules with white opaque cap imprinted with "ZA64" and white opaque body imprinted with "25 mg" in black ink and are supplied as follows: NDC 65841-652-17 in bottle of 28 capsules NDC 65841-652-14 in bottle of 60 capsules NDC 65841-652-16 in bottle of 90 capsules NDC 65841-652-01 in bottle of 100 capsules NDC 65841-652-05 in bottle of 500 capsules NDC 65841-652-10 in bottle of 1000 capsules Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.

授权状态:

Abbreviated New Drug Application

资料单张

Zydus Lifesciences Limited
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SPL MEDGUIDE
Revised: 10/2022
Document Id: 8e90e7b9-efed-46d5-925b-4123ac9d6b37
34391-3
Set id: 6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b
Version: 9
Effective Time: 20221031
Zydus Lifesciences Limited

产品特点

TOPIRAMATE - TOPIRAMATE CAPSULE, COATED PELLETS
ZYDUS LIFESCIENCES LIMITED
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TOPIRAMATE TABLETS AND TOPIRAMATE CAPSULES
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-651-14 in bottle of 60 capsules
Topiramate Capsules USP, 15 mg
60 capsules
Rx only
NDC 65841-652-14 in bottle of 60 capsules
Topiramate Capsules USP, 25 mg
60 capsules
Rx only
TOPIRAMATE
topiramate capsule, coated pellets
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-651
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)
TOPIRAMATE
15 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
GELATIN (UNII: 2G86QN327L)
POVIDONE (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
18mm
FLAVOR
IMPRINT CODE
Z A63;15mg
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-651-
14
60 in 1 BOTTLE; Type 0: Not a Combination
Product
10/14/2009
2
NDC:65841-651-
16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
10/14/2009
3
NDC:65841-651-
01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
10/14/2009
4
NDC:65841-651-
05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
10/14/2009
5
NDC:65841-651-
10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
10/14/2009
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA078877
10/14/2009
TOPIRAMATE
topiramate capsule, coated pellets
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-652
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H7