BICALUTAMIDE tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

BICALUTAMIDE (UNII: A0Z3NAU9DP) (BICALUTAMIDE - UNII:A0Z3NAU9DP)

Dostupné s:

Zydus Lifesciences Limited

INN (Mezinárodní Name):

BICALUTAMIDE

Složení:

BICALUTAMIDE 50 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate. Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2)]. Bicalutamide is contraindicated in: Hypersensitivity Bicalutamide is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or any of the tablet's components. Hypersensitivity reactions including angioneurotic edema and urticaria have been reported. Women Bicalutamide has no indication for women, and should not be used in this population. Pregnancy Bicalutamide can cause fetal harm when administered to a pregnant woman. [see Use in Specific Populations (8.1) ]. Risk Summary Bicalutamide is contraindicated for use in pregnant women because it can cause fetal harm. Bicalutamide is not indicated for use in females. There are no human data on the use of bicalutam

Přehled produktů:

Bicalutamide Tablets USP, 50 mg are white to off-white, round, biconvex, film-coated tablets, debossed with ZE 57 on one side and plain on other side and are supplied as follows: NDC 65841-613-06 in bottle of 30 tablets NDC 65841-613-01 in bottle of 100 tablets NDC 65841-613-05 in bottle of 500 tablets NDC 65841-613-10 in bottle of 1000 tablets NDC 65841-613-77 in cartons of 100 tablets (10 x 10 unit-dose) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

BICALUTAMIDE - BICALUTAMIDE TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
----------
BICALUTAMIDE TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-613-06 in bottle of 30 tablets
Bicalutamide Tablets USP, 50 mg
R only
30 tablets
BICALUTAMIDE
bicalutamide tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-613
x
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BICALUTAMIDE (UNII: A0Z3NAU9DP) (BICALUTAMIDE - UNII:A0Z3NAU9DP)
BICALUTAMIDE
50 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF- WHITE)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
6mm
FLAVOR
IMPRINT CODE
Z E;57
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-
613-06
30 in 1 BOTTLE; Type 0: Not a Combination
Product
07/06/2009
2
NDC:65841-
613-01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
07/06/2009
3
NDC:65841-
613-05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
07/06/2009
4
NDC:65841-
613-10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
07/06/2009
5
NDC:65841-
613-30
10 in 1 CARTON
07/06/2009
5
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
ANDA079089
07/06/2009
LABELER -
Zydus Lifesciences Limited (918596198)
Zydus Lifesciences Limited
REGISTRANT -
Zydus Lifesciences Limited (918596198)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
918596198
ANALYSIS(65841-613) , MANUFACTURE(65841-613)
Revised: 10/2022