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FDA Product

Duloxetine

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

Basic Information

Duloxetine

60760-462

Regulatory Information

60760-462

ANDA208706

C73584

September 5, 2019

USA

These highlights do not include all the information needed to use DULOXETINE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DULOXETINE DELAYED-RELEASE CAPSULES. DULOXETINE delayed-release capsules, for oral use. Initial U.S. Approval: 2004

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

063050751

Active Ingredients

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

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

Code: NX76LV5T8J

Class Code: IACT

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

DULOXETINE HYDROCHLORIDE

Quantity: 60 mg in 1 1

Code: 9044SC542W

Class Code: ACTIM

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

DULOXETINE

Code: O5TNM5N07U

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