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FDA Approval

Modafinil

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

FDA Approval Summary

Company
AvPAK
DUNS: 832926666
Effective Date
June 2, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Modafinil(200 mg in 1 1)

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
50268-571
Application Number
ANDA202566
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 2, 2022
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
ModafinilActive
Code: R3UK8X3U3DClass: ACTIBQuantity: 200 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT

Modafinil

Product Details

NDC Product Code
50268-570
Application Number
ANDA202566
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 2, 2022
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ModafinilActive
Code: R3UK8X3U3DClass: ACTIBQuantity: 100 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
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