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Estradiol

These highlights do not include all the information needed to use ESTRADIOL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for ESTRADIOL TRANSDERMAL SYSTEM. ESTRADIOL transdermal system Initial U.S. Approval: 1975

Approved
Approval ID

d4259bb8-91f8-4587-8ceb-35d44145aec0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 30, 2021

Manufacturers
FDA

Amneal Pharmaceuticals NY LLC

DUNS: 123797875

Products 5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Estradiol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69238-1294
Application NumberANDA211396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estradiol
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateDecember 30, 2023
FDA Product Classification

INGREDIENTS (5)

ESTRADIOLActive
Quantity: 0.075 mg in 1 d
Code: 4TI98Z838E
Classification: ACTIB
OLEYL ALCOHOLInactive
Code: 172F2WN8DV
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
DIPROPYLENE GLYCOLInactive
Code: E107L85C40
Classification: IACT
DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S)Inactive
Code: 83D19O7250
Classification: IACT

Estradiol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69238-1295
Application NumberANDA211396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estradiol
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateDecember 30, 2023
FDA Product Classification

INGREDIENTS (5)

ESTRADIOLActive
Quantity: 0.05 mg in 1 d
Code: 4TI98Z838E
Classification: ACTIB
OLEYL ALCOHOLInactive
Code: 172F2WN8DV
Classification: IACT
DIPROPYLENE GLYCOLInactive
Code: E107L85C40
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S)Inactive
Code: 83D19O7250
Classification: IACT

Estradiol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69238-1293
Application NumberANDA211396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estradiol
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateDecember 30, 2023
FDA Product Classification

INGREDIENTS (5)

OLEYL ALCOHOLInactive
Code: 172F2WN8DV
Classification: IACT
ESTRADIOLActive
Quantity: 0.0375 mg in 1 d
Code: 4TI98Z838E
Classification: ACTIB
DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S)Inactive
Code: 83D19O7250
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
DIPROPYLENE GLYCOLInactive
Code: E107L85C40
Classification: IACT

Estradiol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69238-1447
Application NumberANDA211396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estradiol
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateDecember 30, 2023
FDA Product Classification

INGREDIENTS (5)

DIPROPYLENE GLYCOLInactive
Code: E107L85C40
Classification: IACT
OLEYL ALCOHOLInactive
Code: 172F2WN8DV
Classification: IACT
ESTRADIOLActive
Quantity: 0.025 mg in 1 d
Code: 4TI98Z838E
Classification: ACTIB
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S)Inactive
Code: 83D19O7250
Classification: IACT

Estradiol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69238-1296
Application NumberANDA211396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estradiol
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateDecember 30, 2023
FDA Product Classification

INGREDIENTS (5)

ESTRADIOLActive
Quantity: 0.1 mg in 1 d
Code: 4TI98Z838E
Classification: ACTIB
OLEYL ALCOHOLInactive
Code: 172F2WN8DV
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
DIPROPYLENE GLYCOLInactive
Code: E107L85C40
Classification: IACT
DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S)Inactive
Code: 83D19O7250
Classification: IACT

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Estradiol - FDA Drug Approval Details