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FDA Approval

Decadron

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

FDA Approval Summary

Company
Effective Date
October 1, 2017
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Dexamethasone(0.5 mg in 5 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Decadron

Product Details

NDC Product Code
58463-010
Application Number
ANDA090891
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 1, 2017
Code: 7S5I7G3JQLClass: ACTIBQuantity: 0.5 mg in 5 mL
benzoic acidInactive
Code: 8SKN0B0MIMClass: IACT
alcoholInactive
Code: 3K9958V90MClass: IACT
citric acid monohydrateInactive
Code: 2968PHW8QPClass: IACT
FD&C red no. 40Inactive
Code: WZB9127XOAClass: IACT
propylene glycolInactive
Code: 6DC9Q167V3Class: IACT
sucroseInactive
Code: C151H8M554Class: IACT
trisodium citrate dihydrateInactive
Code: B22547B95KClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
raspberryInactive
Code: 4N14V5R27WClass: IACT
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