MedPath
FDA Product

OXYBUTYNIN CHLORIDE

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

Basic Information

OXYBUTYNIN CHLORIDE

72189-132

Regulatory Information

72189-132

ANDA207138

C73584

August 24, 2020

USA

OXYBUTYNIN CHLORIDE

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

DIRECT RX

079254320

Active Ingredients

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

SODIUM BICARBONATE

Code: 8MDF5V39QO

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

HYPROMELLOSE 2208 (100000 MPA.S)

Code: VM7F0B23ZI

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A

Code: NX76LV5T8J

Class Code: IACT

OXYBUTYNIN CHLORIDE

Quantity: 10 mg in 1 1

Code: L9F3D9RENQ

Class Code: ACTIB

Active Moieties

OXYBUTYNIN

Code: K9P6MC7092

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