EEMT
Physician Labeling ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE Tablets
Approved
Approval ID
1db7b3c7-14e3-43ef-b519-e2b880edbd5b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 22, 2020
Manufacturers
FDA
CREEKWOOD PHARMACEUTICAL, INC,
DUNS: 618997188
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ESTROGENS, ESTERIFIED and METHYLTESTOSTERONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15310-020
Product Classification
G
Generic Name
ESTROGENS, ESTERIFIED and METHYLTESTOSTERONE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 22, 2020
FDA Product Classification
INGREDIENTS (16)
METHYLTESTOSTERONEActive
Quantity: 1.25 mg in 1 1
Code: V9EFU16ZIF
Classification: ACTIB
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ESTROGENS, ESTERIFIEDActive
Quantity: 0.625 mg in 1 1
Code: 3ASP8Q3768
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ESTROGENS, ESTERIFIED and METHYLTESTOSTERONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15310-010
Product Classification
G
Generic Name
ESTROGENS, ESTERIFIED and METHYLTESTOSTERONE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 22, 2020
FDA Product Classification
INGREDIENTS (16)
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
METHYLTESTOSTERONEActive
Quantity: 2.5 mg in 1 1
Code: V9EFU16ZIF
Classification: ACTIB
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ESTROGENS, ESTERIFIEDActive
Quantity: 1.25 mg in 1 1
Code: 3ASP8Q3768
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT