Duloxetine Hydrochloride Delayed Release
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
Approved
Approval ID
8f9d39aa-9d3b-461f-a74a-71a0f936b57e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 14, 2019
Manufacturers
FDA
Innovida Pharmaceutique Corporation
DUNS: 080892908
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Duloxetine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71800-011
Application NumberANDA203088
Product Classification
M
Marketing Category
C73584
G
Generic Name
Duloxetine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2019
FDA Product Classification
INGREDIENTS (19)
duloxetine hydrochlorideActive
Quantity: 40 mg in 1 1
Code: 9044SC542W
Classification: ACTIM
ShellacInactive
Code: 46N107B71O
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
AmmoniaInactive
Code: 5138Q19F1X
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Potassium HydroxideInactive
Code: WZH3C48M4T
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type AInactive
Code: NX76LV5T8J
Classification: IACT
FD&C Blue no. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327L
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UM
Classification: IACT
Ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT