Basic Information
Duloxetine
68382-387
Regulatory Information
68382-387
ANDA090739
C73584
October 19, 2020
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
17
Company Information
156861945
Active Ingredients
Inactive Ingredients
FD&C BLUE NO. 1
Code: H3R47K3TBD
Class Code: IACT
GELATIN
Code: 2G86QN327L
Class Code: IACT
SUCROSE
Code: C151H8M554
Class Code: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)
Code: G4U024CQK6
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
HYPROMELLOSES
Code: 3NXW29V3WO
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
TRIETHYL CITRATE
Code: 8Z96QXD6UM
Class Code: IACT
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
Active Moieties
DULOXETINE
Code: O5TNM5N07U