Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Zydus Lifesciences Limited
650199482
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zydus Lifesciences Limited
Viona Pharmaceuticals Inc
Zydus Lifesciences Limited
863362789
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
72578-006Application Number
ANDA209966Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 10, 2023ModafinilActive
Code: R3UK8X3U3DClass: ACTIBQuantity: 200 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693YClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
Modafinil
Product Details
NDC Product Code
72578-005Application Number
ANDA209966Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 10, 2023ModafinilActive
Code: R3UK8X3U3DClass: ACTIBQuantity: 100 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693YClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT