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FDA Approval

Desoxyn

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

FDA Approval Summary

Company
Key Therapeutics
DUNS: 080318791
Effective Date
September 8, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Metamfetamine(5 mg in 1 1)

Products1

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

Desoxyn

Product Details

NDC Product Code
70868-820
Application Number
NDA005378
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
September 7, 2022
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
Code: 997F43Z9CVClass: ACTIBQuantity: 5 mg in 1 1
AMINOBENZOATE SODIUMInactive
Code: 75UI7QUZ5JClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
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