Cenestin
Cenestin (synthetic conjugated estrogens, A) Tablets
Approved
Approval ID
1cd07b54-f66f-4040-9058-462324267196
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2004
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
synthetic conjugated estrogens, A
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5415
Application NumberNDA020992
Product Classification
M
Marketing Category
C73594
G
Generic Name
synthetic conjugated estrogens, A
Product Specifications
Route of AdministrationORAL
Effective DateDecember 9, 2010
FDA Product Classification
INGREDIENTS (11)
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
ESTROGENS, CONJUGATED SYNTHETIC AActive
Quantity: 0.45 mg in 1 1
Code: JM2621P2LS
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
synthetic conjugated estrogens, A
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4879
Application NumberNDA020992
Product Classification
M
Marketing Category
C73594
G
Generic Name
synthetic conjugated estrogens, A
Product Specifications
Route of AdministrationORAL
Effective DateDecember 9, 2010
FDA Product Classification
INGREDIENTS (11)
ESTROGENS, CONJUGATED SYNTHETIC AActive
Quantity: 0.625 mg in 1 1
Code: JM2621P2LS
Classification: ACTIB
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
synthetic conjugated estrogens, A
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-1432
Application NumberNDA020992
Product Classification
M
Marketing Category
C73594
G
Generic Name
synthetic conjugated estrogens, A
Product Specifications
Route of AdministrationORAL
Effective DateDecember 9, 2010
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
ESTROGENS, CONJUGATED SYNTHETIC AActive
Quantity: 1.25 mg in 1 1
Code: JM2621P2LS
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT