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
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