Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
PD-Rx Pharmaceuticals, Inc.
156893695
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
156893695
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
43063-921Application Number
ANDA078012Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 1, 2023SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
GemfibrozilActive
Code: Q8X02027X3Class: ACTIBQuantity: 600 mg in 1 1
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT