Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Apotex Inc
209429182
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Modafinil
Product Details
NDC Product Code
60505-2526Application Number
ANDA077667Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 4, 2023SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ModafinilActive
Code: R3UK8X3U3DClass: ACTIBQuantity: 100 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8Class: IACT
Modafinil
Product Details
NDC Product Code
60505-2527Application Number
ANDA077667Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 4, 2023SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8Class: IACT
ModafinilActive
Code: R3UK8X3U3DClass: ACTIBQuantity: 200 mg in 1 1