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FDA Product

Duloxetine

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

Basic Information

Duloxetine

45865-813

Regulatory Information

45865-813

ANDA090723

C73584

December 27, 2019

USA

DULOXETINE delayed-release capsules USP for oral use. Initial U.S. Approval: 2004

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

833685915

Active Ingredients

GELATIN

Code: 2G86QN327L

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

GLYCINE

Code: TE7660XO1C

Class Code: IACT

HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)

Code: G4U024CQK6

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

DULOXETINE HYDROCHLORIDE

Quantity: 30 mg in 1 1

Code: 9044SC542W

Class Code: ACTIM

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

Active Moieties

DULOXETINE

Code: O5TNM5N07U

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