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FDA Product

UroAv-81

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

Basic Information

UroAv-81

15338-502

Regulatory Information

15338-502

May 21, 2018

UroAv-81 Tablets (Product contract packaged by Apace Packaging, LLC)

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

361961142

Active Ingredients

POLYETHYLENE GLYCOLS

Code: 3WJQ0SDW1A

Class Code: IACT

CROSPOVIDONE

Code: 68401960MK

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

LACTOSE

Code: J2B2A4N98G

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

METHENAMINE

Quantity: 81 mg in 1 1

Code: J50OIX95QV

Class Code: ACTIB

PHENYL SALICYLATE

Quantity: 32.4 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

SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS

Quantity: 40.8 mg in 1 1

Code: KH7I04HPUU

Class Code: ACTIB

Active Moieties

SODIUM CATION

Code: LYR4M0NH37

METHENAMINE

Code: J50OIX95QV

PHENYL SALICYLATE

Code: 28A37T47QO

HYOSCYAMINE

Code: PX44XO846X

METHYLENE BLUE CATION

Code: ZMZ79891ZH

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