Basic Information
Duloxetine
60760-462
Regulatory Information
60760-462
ANDA208706
C73584
September 5, 2019
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
1
Company Information
063050751
Active Ingredients
ALCOHOL
Code: 3K9958V90M
Class Code: IACT
AMMONIA
Code: 5138Q19F1X
Class Code: IACT
HYPROMELLOSES
Code: 3NXW29V3WO
Class Code: IACT
SUCROSE
Code: C151H8M554
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
Code: NX76LV5T8J
Class Code: IACT
TRIETHYL CITRATE
Code: 8Z96QXD6UM
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
ISOPROPYL ALCOHOL
Code: ND2M416302
Class Code: IACT
FD&C BLUE NO. 2
Code: L06K8R7DQK
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
BUTYL ALCOHOL
Code: 8PJ61P6TS3
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
POTASSIUM HYDROXIDE
Code: WZH3C48M4T
Class Code: IACT
WATER
Code: 059QF0KO0R
Class Code: IACT
Active Moieties
DULOXETINE
Code: O5TNM5N07U