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FDA Approval

Cymbalta

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

FDA Approval Summary

Company
Effective Date
October 18, 2011
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Duloxetine(60 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Eli Lilly and Company

006421325

Manufacturing Establishments6

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

Lilly del Caribe, Inc. (PR06)

H.J. Harkins Company, Inc.

Eli Lilly and Company

828519848

Sharp - Conshohocken

H.J. Harkins Company, Inc.

Eli Lilly and Company

002346625

Evonik Degussa Corporation

H.J. Harkins Company, Inc.

Eli Lilly and Company

130890994

Eli Lilly and Company (Indianapolis)

H.J. Harkins Company, Inc.

Eli Lilly and Company

006421325

Lilly del Caribe, Inc. (PR01)

H.J. Harkins Company, Inc.

Eli Lilly and Company

806917345

Sharp - Allentown

H.J. Harkins Company, Inc.

Eli Lilly and Company

143696495

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
52959-892
Application Number
NDA021427
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
October 18, 2011
GelatinInactive
Code: 2G86QN327LClass: IACT
Code: 9044SC542WClass: ACTIMQuantity: 60 mg in 1 1
HypromellosesInactive
Code: 3NXW29V3WOClass: IACT
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)Inactive
Code: 24P2YXD2PWClass: IACT
SucroseInactive
Code: C151H8M554Class: IACT
Titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
Sodium lauryl sulfateInactive
Code: 368GB5141JClass: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT
Triethyl citrateInactive
Code: 8Z96QXD6UMClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
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