TAMOXIFEN CITRATE tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

TAMOXIFEN CITRATE (UNII: 7FRV7310N6) (TAMOXIFEN - UNII:094ZI81Y45)

Mevcut itibaren:

Zydus Lifesciences Limited

INN (International Adı):

TAMOXIFEN CITRATE

Kompozisyon:

TAMOXIFEN 10 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Metastatic Breast Cancer Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy. Adjuvant Treatment of Breast Cancer Tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. Tamoxifen citrate tablets are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. The estrogen and progesterone receptor values may help to predict whe

Ürün özeti:

Tamoxifen Citrate Tablet 15.2 mg is equivalent to tamoxifen 10 mg. Tamoxifen Citrate Tablets USP, 10 mg are white to off-white, round, film-coated tablets, with beveled-edge, debossed with "826" on one side and plain on the other side and are supplied as follows: NDC 70771-1184-6 in bottle of 60 tablets NDC 70771-1184-9 in bottle of 90 tablets NDC 70771-1184-1 in bottle of 100 tablets NDC 68382-826-28 in bottle of 180 tablets Tamoxifen Citrate Tablet 30.4 mg is equivalent to tamoxifen 20 mg. Tamoxifen Citrate Tablets USP, 20 mg are white to off-white, round, film-coated tablets, with beveled-edge, debossed with "827" on one side and plain on the other side and are supplied as follows: NDC 70771-1185-3 in bottle of 30 tablets NDC 70771-1185-6 in bottle of 60 tablets NDC 70771-1185-9 in bottle of 90 tablets NDC 70771-1185-1 in bottle of 100 tablets NDC 68382-827-10 in bottle of 1,000 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

Zydus Lifesciences Limited
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SPL MEDGUIDE
Revised: 9/2023
Document Id: 4d48092a-f1fb-4bcd-b109-b48cffacfaec
34391-3
Set id: 70052366-80f3-41bc-b2dd-c1efe9317243
Version: 6
Effective Time: 20230928
Zydus Lifesciences Limited

Ürün özellikleri

TAMOXIFEN CITRATE- TAMOXIFEN CITRATE TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
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TAMOXIFEN CITRATE TABLETS, USP
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1184-1 in bottle of 100 tablets
Tamoxifen Citrate Tablets USP, 10 mg
Rx Only
100 tablets
NDC 70771-1185-1 in bottle of 100 tablets
Tamoxifen Citrate Tablets USP, 20 mg
Rx Only
100 tablets
TAMOXIFEN CITRATE
tamoxifen citrate tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1184
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
TAMOXIFEN CITRATE (UNII: 7FRV7310N6) (TAMOXIFEN - UNII:094ZI81Y45)
TAMOXIFEN
10 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF-WHITE)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
7mm
FLAVOR
IMPRINT CODE
826
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1184-6
60 in 1 BOTTLE; Type 0: Not a Combination
Product
01/03/2018
2
NDC:70771-
1184-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
01/03/2018
3
NDC:70771-
1184-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
01/03/2018
4
NDC:70771-
1184-8
180 in 1 BOTTLE; Type 0: Not a Combination
Product
01/03/2018
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA206694
01/03/2018
TAMOXIFEN CITRATE
tamoxifen citrate tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1185
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
TAMOXIFEN CITRATE (UNII: 7FRV7310N6) (TAMOXIFEN - UNII:094ZI81Y45)
TAMOXIFEN
20 mg