Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Catalent Greenville, Inc.
Mayne Pharma Commercial LLC
118812386
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methamphetamine Hydrochloride
Product Details
NDC Product Code
68308-115Application Number
ANDA091189Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 5, 2023STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MetamfetamineActive
Code: 997F43Z9CVClass: ACTIBQuantity: 5 mg in 1 1