Esterified Estrogens and Methyltestosterone
Physician Labeling Esterified Estrogens and Methyltestosterone Tablets Full Strength and Half Strength
Approved
Approval ID
5845e789-8191-46f9-bbd0-79fb0c716601
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 16, 2010
Manufacturers
FDA
Tal Pharma LLC
DUNS: 832524784
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Esterified Estrogens and Methyltestosterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50220-002
Product Classification
G
Generic Name
Esterified Estrogens and Methyltestosterone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 16, 2010
FDA Product Classification
INGREDIENTS (8)
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
METHYLTESTOSTERONEActive
Quantity: 2.5 mg in 1 1
Code: V9EFU16ZIF
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ESTRONE SODIUM SULFATEActive
Quantity: 1.25 mg in 1 1
Code: 6K6FDA543A
Classification: ACTIB
Esterified Estrogens and Methyltestosterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50220-001
Product Classification
G
Generic Name
Esterified Estrogens and Methyltestosterone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 16, 2010
FDA Product Classification
INGREDIENTS (6)
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
METHYLTESTOSTERONEActive
Quantity: 1.25 mg in 1 1
Code: V9EFU16ZIF
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ESTRONE SODIUM SULFATEActive
Quantity: 0.625 mg in 1 1
Code: 6K6FDA543A
Classification: ACTIB