MEMANTINE HYDROCHLORIDE tablet, film coated

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T)

Fáanlegur frá:

Zydus Lifesciences Limited

INN (Alþjóðlegt nafn):

MEMANTINE HYDROCHLORIDE

Samsetning:

MEMANTINE HYDROCHLORIDE 5 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Memantine hydrochloride tablets, USP are indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Memantine hydrochloride tablets are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. Risk Summary There are no adequate data on the developmental risk associated with the use of memantine in pregnant women. Adverse developmental effects (decreased body weight, and skeletal ossification) were observed in the offspring of rats administered memantine during pregnancy at doses associated with minimal maternal toxicity. These doses are higher than those used in humans at the maximum recommended daily dose of memantine [see Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data

Vörulýsing:

Memantine Hydrochloride Tablets USP, 5 mg are white to off white, capsule shaped, biconvex film coated tablets debossed with 'ZF' on one side and '41' on other side and are supplied as below. NDC 70771-1119-6 in bottle of 60 tablets NDC 70771-1119-1 in bottle of 100 tablets NDC 70771-1119-5 in bottle of 500 tablets NDC 70771-1119-0 in bottle of 1000 tablets NDC 70771-1119-4 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Memantine Hydrochloride Tablets USP, 10 mg are white to off white, capsule shaped, biconvex film coated tablets debossed with 'ZF 40' on one side and other side is plain and are supplied as below. NDC 70771-1120-6 in bottle of 60 tablets NDC 70771-1120-1 in bottle of 100 tablets NDC 70771-1120-5 in bottle of 500 tablets NDC 70771-1120-0 in bottle of 1000 tablets NDC 70771-1120-4 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

MEMANTINE HYDROCHLORIDE - MEMANTINE HYDROCHLORIDE TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
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MEMANTINE HYDROCHLORIDE TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1119-1 in bottle of 100 tablets
Memantine Hydrochloride Tablets USP, 5 mg
Rx only
100 tablets
NDC 70771-1120-1 in bottle of 100 tablets
Memantine Hydrochloride Tablets USP, 10 mg
Rx only
100 tablets
MEMANTINE HYDROCHLORIDE
memantine hydrochloride tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1119
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE -
UNII:W8O17SJF3T)
MEMANTINE
HYDROCHLORIDE
5 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF-WHITE)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
9mm
FLAVOR
IMPRINT CODE
Z F;41
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1119-4
100 in 1 CARTON
09/28/2017
1
NDC:70771-
1119-2
1 in 1 BLISTER PACK; Type 0: Not a Combination
Product
2
NDC:70771-
1119-6
60 in 1 BOTTLE; Type 0: Not a Combination
Product
09/28/2017
3
NDC:70771-
1119-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
09/28/2017
4
NDC:70771-
1119-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
09/28/2017
5
NDC:70771-
1119-0
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
09/28/2017
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA090961
09/28/2017
MEMANTINE HYDROCHLORIDE
memantine hydro