GALANTAMINE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GALANTAMINE HYDROBROMIDE (UNII: MJ4PTD2VVW) (GALANTAMINE - UNII:0D3Q044KCA)

Available from:

Zydus Lifesciences Limited

INN (International Name):

GALANTAMINE HYDROBROMIDE

Composition:

GALANTAMINE 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Galantamine Tablets, USP are indicated for the treatment of mild to moderate dementia of the Alzheimer's type. Galantamine tablets are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. In studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically. Galantamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In rats, administration of galantamine (oral doses of 2, 8, or 16 mg/kg/day), from day 14 (females) or day 60 (males) prior to mating and continuing in females through the period of organogenesis, resulted in an increased incidence of fetal skeletal variations at the two highest doses. The

Product summary:

Galantamine Tablets, USP equivalent to 4 mg of galantamine are light-pink, round , biconvex, film-coated tablets debossed with '77' on one side and 'Z' on the other side and are supplied as follows: NDC 65841-755-14 in bottle of 60 tablets NDC 65841-755-01 in bottle of 100 tablets NDC 65841-755-10 in bottle of 1000 tablets NDC 65841-755-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Galantamine Tablets, USP equivalent to 8 mg of galantamine are off-white, round, biconvex, film-coated tablets debossed with '78' on one side and 'Z' on the other side and are supplied as follows: NDC 65841-756-14 in bottle of 60 tablets NDC 65841-756-01 in bottle of 100 tablets NDC 65841-756-10 in bottle of 1000 tablets NDC 65841-756-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Galantamine Tablets, USP equivalent to 12 mg of galantamine are off-white, round, biconvex, film-coated tablets debossed with '79' on one side and 'Z' on the other side and are supplied as follows: NDC 65841-757-14 in bottle of 60 tablets NDC 65841-757-01 in bottle of 100 tablets NDC 65841-757-10 in bottle of 1000 tablets NDC 65841-757-77 in unit-dose blister carton 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GALANTAMINE - GALANTAMINE TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
----------
GALANTAMINE TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-755-14 in bottle of 60 tablets
Galantamine Tablets USP, 4 mg
R only
60 tablets
NDC 65841-756-14 in bottle of 60 tablets
Galantamine Tablets USP, 8 mg
R only
60 tablets
x
x
NDC 65841-757-14 in bottle of 60 tablets
Galantamine Tablets USP, 12 mg
R only
60 tablets
x
GALANTAMINE
galantamine tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-755
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
GALANTAMINE HYDROBROMIDE (UNII: MJ4PTD2VVW) (GALANTAMINE -
UNII:0D3Q044KCA)
GALANTAMINE
4 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
PRODUCT CHARACTERISTICS
COLOR
PINK (LIGHT PINK)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
6mm
FLAVOR
IMPRINT CODE
77;Z
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-
755-14
60 in 1 BOTTLE; Type 0: Not a Combination
Product
10/10/2011
2
NDC:65841-
755-01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
10/10/2011
3
NDC:65841-
755-10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
10/10/2011
4
NDC:65841-
755-77
10 in 1 CARTON
10/10/2011
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
ANDA078898
10/10/2011
GALANTAMINE
galantamine tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-756
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
GALANTAM