MedPath
FDA Product

Atomoxetine

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

Basic Information

Atomoxetine

0093-3548

Regulatory Information

0093-3548

ANDA079022

C73584

April 21, 2023

USA

These highlights do not include all the information needed to use ATOMOXETINE CAPSULES safely and effectively. See full prescribing information for ATOMOXETINE CAPSULES.ATOMOXETINE capsules, for oral useInitial U.S. Approval: 2002

HUMAN PRESCRIPTION DRUG LABEL

18

Company Information

001627975

Active Ingredients

ATOMOXETINE HYDROCHLORIDE

Quantity: 100 mg in 1 1

Code: 57WVB6I2W0

Class Code: ACTIM

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

ATOMOXETINE

Code: ASW034S0B8

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