DIPYRIDAMOLE tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C)

Prieinama:

Zydus Lifesciences Limited

INN (Tarptautinis Pavadinimas):

DIPYRIDAMOLE

Sudėtis:

DIPYRIDAMOLE 25 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement. Hypersensitivity to dipyridamole and any of the other components.

Produkto santrauka:

Dipyridamole Tablets USP, 25 mg are light yellow, round, biconvex, film-coated tablets debossed with 'ZE 43' on one side and plain on the other side are supplied as follows: NDC 65841-662-01 in bottle of 100 tablets NDC 65841-662-05 in bottle of 500 tablets NDC 65841-662-10 in bottle of 1000 tablets NDC 65841-662-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Dipyridamole Tablets USP, 50 mg are light yellow, round, biconvex, beveled-edge, film-coated tablets debossed with 'ZE 49' on one side and plain on the other side are supplied as follows: NDC 65841-663-01 in bottle of 100 tablets NDC 65841-663-05 in bottle of 500 tablets NDC 65841-663-10 in bottle of 1000 tablets NDC 65841-663-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Dipyridamole Tablets USP, 75 mg are light yellow, round, biconvex, beveled-edge, film-coated tablets debossed with 'ZE 50' on one side and plain on the other side are supplied as follows: NDC 65841-664-01 in bottle of 100 tablets NDC 65841-664-05 in bottle of 500 tablets NDC 65841-664-10 in bottle of 1000 tablets NDC 65841-664-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep out of reach of children. Dispense in a tight, light-resistant container. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Manufactured by: Cadila Healthcare Ltd. Baddi, India Rev.: 09/11 Rivision Date : 2012/03/22

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

DIPYRIDAMOLE - DIPYRIDAMOLE TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
----------
DIPYRIDAMOLE TABLETS, USP
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-662-01 in bottle of 100 tablets
Dipyridamole Tablets USP, 25 mg
R only
100 tablets
ZYDUS
NDC 65841-663-01 in bottle of 100 tablets
Dipyridamole Tablets USP, 50 mg
R only
100 tablets
ZYDUS
x
x
NDC 65841-664-01 in bottle of 100 tablets
Dipyridamole Tablets USP, 75 mg
R only
100 tablets
ZYDUS
DIPYRIDAMOLE
dipyridamole tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-662
ROUTE OF ADMINISTRATION
ORAL
x
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C)
DIPYRIDAMOLE
25 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
PRODUCT CHARACTERISTICS
COLOR
YELLOW (LIGHT YELLOW)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
6mm
FLAVOR
IMPRINT CODE
Z E;43
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-
662-01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
05/22/2008
2
NDC:65841-
662-05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
05/22/2008
3
NDC:65841-
662-10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
05/22/2008
4
NDC:65841-
662-77
10 in 1 CARTON
05/22/2008
4
10 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA040874
05/22/2008
DIPYRIDAMOLE
dipyridamole tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-663
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
B