Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Blenheim Pharmacal, Inc.
171434587
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Blenheim Pharmacal, Inc.
Blenheim Pharmacal, Inc.
Blenheim Pharmacal, Inc.
171434587
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
10544-569Application Number
ANDA074270Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 24, 2015HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671PClass: IACT
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
GemfibrozilActive
Code: Q8X02027X3Class: ACTIBQuantity: 600 mg in 1 1