MESALAMINE tablet, delayed release

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

MESALAMINE (UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC)

متاح من:

Zydus Lifesciences Limited

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Mesalamine delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults. Limitations of Use: Safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established. Mesalamine delayed-release tablets are contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine delayed-release tablets [see Warnings and Precautions (5.3), Adverse Reactions (6.2), and Description (11)] . Risk Summary Limited published data on mesalamine use in pregnant women are insufficient to inform a drug-associated risk. No fetal harm was observed in animal reproduction studies of mesalamine in rats and rabbits at oral doses approximately 0.97 times (rat) and 1.95 times (rabbit) the recommended human dose [see Data ]. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated back

ملخص المنتج:

Mesalamine Delayed-release Tablets, USP 800 mg are reddish-brown colored, capsule-shaped, biconvex, enteric coated tablets, imprinted with "435" on one side and plain on other side and are supplied as follows: NDC 70771-1110-8 in bottles of 180 tablets NDC 70771-1110-4 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].   Protect from moisture. Tablets can be dispensed without desiccant for up to 6 weeks.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

MESALAMINE - MESALAMINE TABLET, DELAYED RELEASE
ZYDUS LIFESCIENCES LIMITED
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MESALAMINE DELAYED-RELEASE TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1110-8 in bottle of 180 tablets
Mesalamine Delayed-release Tablets USP, 800 mg
R only
180 tablets
MESALAMINE
mesalamine tablet, delayed release
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1110
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
x
MESALAMINE (UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC)
MESALAMINE
800 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID (UNII: 1CS02G8656)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMMONIA (UNII: 5138Q19F1X)
SHELLAC (UNII: 46N107B71O)
PRODUCT CHARACTERISTICS
COLOR
RED (REDDISH-BROWN)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
19mm
FLAVOR
IMPRINT CODE
435
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1110-8
180 in 1 BOTTLE; Type 0: Not a Combination
Product
08/02/2018
2
NDC:70771-
1110-4
10 in 1 CARTON
08/02/2018
2
NDC:70771-
1110-2
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
ANDA203286
08/02/2018
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(70771-1110) , MANUFACTURE(70771-1110)
Re