AZATHIOPRINE tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L)

Dostopno od:

Zydus Lifesciences Limited

INN (mednarodno ime):

AZATHIOPRINE

Sestava:

AZATHIOPRINE 50 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Azathioprine tablets, USP are indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Azathioprine tablets, USP are indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody, and other variables. The effect of azathioprine tablets on these variables has not been tested in controlled trials. Azathioprine tablets, USP are indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms. Aspirin, non-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with azathioprine tablets. The combined use of azathioprine tablets with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for

Povzetek izdelek:

Azathioprine Tablets USP, 50 mg are yellow, round, flat, beveled edge tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "59" and other side is plain and are supplied as follows: NDC 65841-602-01 in bottles of 100 tablets NDC 65841-602-05 in bottles of 500 tablets Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature] in a dry place and protect from light. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

AZATHIOPRINE - AZATHIOPRINE TABLET
ZYDUS LIFESCIENCES LIMITED
----------
AZATHIOPRINE TABLETS, USP
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-602-01 in bottle of 100 tablets
Azathioprine Tablets USP, 50 mg
100 tablets
Rx only
AZATHIOPRINE
azathioprine tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-602
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L)
AZ ATHIOPRINE
50 mg
Zydus Lifesciences Limited
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
PRODUCT CHARACTERISTICS
COLOR
YELLOW (YELLOW)
SCORE
2 pieces
SHAPE
ROUND (ROUND)
SIZE
8mm
FLAVOR
IMPRINT CODE
Z C;59
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-602-
01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
07/11/2007
2
NDC:65841-602-
05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
07/11/2007
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA077621
07/11/2007
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (918596198)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
918596198
ANALYSIS(65841-602) , MANUFACTURE(65841-602)
Revised: 8/2022