METHITEST
METHITEST™ (Methyltestosterone) Tablets, USP, CIII
Approved
Approval ID
77bb4ef4-c10e-4acc-8225-651d003f4561
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 28, 2019
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
METHYLTESTOSTERONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-7037
Application NumberANDA080767
Product Classification
M
Marketing Category
C73584
G
Generic Name
METHYLTESTOSTERONE
Product Specifications
Route of AdministrationORAL
Effective DateMay 28, 2019
FDA Product Classification
INGREDIENTS (9)
METHYLTESTOSTERONEActive
Quantity: 10 mg in 1 1
Code: V9EFU16ZIF
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT