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
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
AMMONIA
Code: 5138Q19F1X
Class Code: IACT
Active Moieties
DULOXETINE
Code: O5TNM5N07U