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FDA Approval

Gemfibrozil

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

FDA Approval Summary

Company
Effective Date
January 3, 2014
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Gemfibrozil(600 mg in 1 1)

Products1

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

Gemfibrozil

Product Details

NDC Product Code
33261-146
Application Number
ANDA075034
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 3, 2014
Code: Q8X02027X3Class: ACTIBQuantity: 600 mg in 1 1
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671PClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8Class: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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