MedPath
FDA Approval

Cymbalta

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
July 22, 2011
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Duloxetine(20 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Rebel Distributors Corp

Rebel Distributors Corp

118802834

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cymbalta

Product Details

NDC Product Code
21695-657
Application Number
NDA021427
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 4, 2010
Code: 9044SC542WClass: ACTIMQuantity: 20 mg in 1 1
GelatinInactive
Code: 2G86QN327LClass: IACT
HypromellosesInactive
Code: 3NXW29V3WOClass: IACT
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)Inactive
Code: 24P2YXD2PWClass: IACT
Sodium lauryl sulfateInactive
Code: 368GB5141JClass: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT
Titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
SucroseInactive
Code: C151H8M554Class: IACT
Triethyl citrateInactive
Code: 8Z96QXD6UMClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
© Copyright 2025. All Rights Reserved by MedPath