MedPath
FDA Product

Duloxetine Delayed-Release

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

Basic Information

Duloxetine Delayed-Release

51407-819

Regulatory Information

51407-819

ANDA203088

C73584

July 13, 2023

USA

DULOXETINE DELAYED-RELEASE CAPSULES. 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

603184490

Active Ingredients

TALC

Code: 7SEV7J4R1U

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER

Code: NX76LV5T8J

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

DULOXETINE HYDROCHLORIDE

Quantity: 60 mg in 1 1

Code: 9044SC542W

Class Code: ACTIM

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

Active Moieties

DULOXETINE

Code: O5TNM5N07U

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