DOXAZOSIN tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

DOXAZOSIN MESYLATE (UNII: 86P6PQK0MU) (DOXAZOSIN - UNII:NW1291F1W8)

Prieinama:

Zydus Lifesciences Limited

INN (Tarptautinis Pavadinimas):

DOXAZOSIN MESYLATE

Sudėtis:

DOXAZOSIN 1 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

      Doxazosin tablets are indicated for the treatment of the signs and symptoms of BPH. Doxazosin tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). N

Produkto santrauka:

Each doxazosin tablet, USP for oral administration contains 1 mg or 2 mg or 4 mg or 8 mg of doxazosin as 1.213 mg or 2.426 mg or 4.852 mg or 9.703 mg of doxazosin mesylate, respectively. Doxazosin tablets USP, 1 mg are white to off-white, round biconvex scored tablets debossed with '783' on one side and score line on another side and are supplied as: NDC 70771-1112-3 in bottle of 30 tablets NDC 70771-1112-1 in bottle of 100 tablets NDC 70771-1112-0 in bottle of 1,000 tablets NDC 70771-1112-4 in cartons of 100 tablets (10 x 10 unit-dose) Doxazosin tablets USP, 2 mg are light pink to pink, mottled, round biconvex scored tablets debossed with '784' on one side and score line on another side and are supplied as: NDC 70771-1113-3 in bottle of 30 tablets NDC 70771-1113-1 in bottle of 100 tablets NDC 70771-1113-0 in bottle of 1,000 tablets NDC 70771-1113-4 in cartons of 100 tablets (10 x 10 unit-dose) Doxazosin tablets USP, 4 mg are light pink to pink, mottled, capsule shaped, biconvex scored tablets debossed with '785' on one side and score line on another side and are supplied as: NDC 70771-1114-3 in bottle of 30 tablets NDC 70771-1114-1 in bottle of 100 tablets NDC 70771-1114-0 in bottle of 1,000 tablets NDC 70771-1114-4 in cartons of 100 tablets (10 x 10 unit-dose) Doxazosin tablets USP, 8 mg are light purple to purple, mottled, round biconvex scored tablets debossed with '786' on one side and score line on another side and are supplied as: NDC 70771-1115-3 in bottle of 30 tablets NDC 70771-1115-1 in bottle of 100 tablets NDC 70771-1115-0 in bottle of 1,000 tablets NDC 70771-1115-4 in cartons of 100 tablets (10 x 10 unit-dose) Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

DOXAZOSIN - DOXAZOSIN TABLET
ZYDUS LIFESCIENCES LIMITED
----------
DOXAZOSIN TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1112-1 in bottle of 100 Tablets
Doxazosin Tablets USP, 1 mg
Rx only
100 Tablets
NDC 70771-1113-1 in bottle of 100 Tablets
Doxazosin Tablets USP, 2 mg
Rx only
100 Tablets
NDC 70771-1114-1 in bottle of 100 Tablets
Doxazosin Tablets USP, 4 mg
Rx only
100 Tablets
NDC 70771-1115-1 in bottle of 100 Tablets
Doxazosin Tablets USP, 8 mg
Rx only
100 Tablets
DOXAZOSIN
doxazosin tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1112
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
DOXAZOSIN MESYLATE (UNII: 86P6PQK0MU) (DOXAZOSIN - UNII:NW1291F1W8)
DOXAZ OSIN
1 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF-WHITE)
SCORE
2 pieces
SHAPE
ROUND (ROUND BICONVEX)
SIZE
7mm
FLAVOR
IMPRINT CODE
783
CONTAINS
PACKAGING
MARKETING START
MARKETING END
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1112-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
08/31/2017
2
NDC:70771-
1112-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
08/31/2017
3
NDC:70771-
1112-0
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
08/31/2017
4
NDC:70771-
1112-4
10 in 1 CARTON
08/31/2017
4
NDC:70771-
1112-2
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
ANDA208719
08/31/2017
DOXAZOSIN
doxazosin tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1113
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENG