MedPath
FDA Product

URIMAR-T CAPS

Product approved by U.S. Food and Drug Administration (US)

Basic Information

URIMAR-T CAPS

28595-224

Regulatory Information

28595-224

July 6, 2023

URIMAR-T™ CAPS

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

792272861

Active Ingredients

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

FD&C RED NO. 3

Code: PN2ZH5LOQY

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

METHENAMINE

Quantity: 120 mg in 1 1

Code: J50OIX95QV

Class Code: ACTIB

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Quantity: 40.8 mg in 1 1

Code: 593YOG76RN

Class Code: ACTIB

PHENYL SALICYLATE

Quantity: 36.2 mg in 1 1

Code: 28A37T47QO

Class Code: ACTIB

METHYLENE BLUE

Quantity: 10.8 mg in 1 1

Code: T42P99266K

Class Code: ACTIB

HYOSCYAMINE SULFATE

Quantity: 0.12 mg in 1 1

Code: F2R8V82B84

Class Code: ACTIB

Active Moieties

METHENAMINE

Code: J50OIX95QV

PHENYL SALICYLATE

Code: 28A37T47QO

METHYLENE BLUE CATION

Code: ZMZ79891ZH

SODIUM CATION

Code: LYR4M0NH37

HYOSCYAMINE

Code: PX44XO846X

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