LYLLANA
These highlights do not include all the information needed to use LYLLANA safely and effectively. See full prescribing information for LYLLANA. LYLLANA (estradiol transdermal system) Initial U.S. Approval: 1975
Approved
Approval ID
09c472c6-a38a-4a3d-b048-6fefd52e2ad3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 20, 2022
Manufacturers
FDA
Amneal Pharmaceuticals 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 Code65162-228
Application NumberANDA211396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estradiol
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 20, 2022
FDA Product Classification
INGREDIENTS (5)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S)Inactive
Code: 83D19O7250
Classification: IACT
ESTRADIOLActive
Quantity: 0.1 mg in 1 d
Code: 4TI98Z838E
Classification: ACTIB
OLEYL ALCOHOLInactive
Code: 172F2WN8DV
Classification: IACT
DIPROPYLENE GLYCOLInactive
Code: E107L85C40
Classification: IACT
Estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-150
Application NumberANDA211396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estradiol
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 20, 2022
FDA Product Classification
INGREDIENTS (5)
OLEYL ALCOHOLInactive
Code: 172F2WN8DV
Classification: IACT
DIPROPYLENE GLYCOLInactive
Code: E107L85C40
Classification: IACT
ESTRADIOLActive
Quantity: 0.075 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 Code65162-148
Application NumberANDA211396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estradiol
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 20, 2022
FDA Product Classification
INGREDIENTS (5)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
OLEYL ALCOHOLInactive
Code: 172F2WN8DV
Classification: IACT
DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S)Inactive
Code: 83D19O7250
Classification: IACT
ESTRADIOLActive
Quantity: 0.0375 mg in 1 d
Code: 4TI98Z838E
Classification: ACTIB
DIPROPYLENE GLYCOLInactive
Code: E107L85C40
Classification: IACT
Estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-126
Application NumberANDA211396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estradiol
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 20, 2022
FDA Product Classification
INGREDIENTS (5)
OLEYL ALCOHOLInactive
Code: 172F2WN8DV
Classification: IACT
DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S)Inactive
Code: 83D19O7250
Classification: IACT
ESTRADIOLActive
Quantity: 0.025 mg in 1 d
Code: 4TI98Z838E
Classification: ACTIB
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 Code65162-149
Application NumberANDA211396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estradiol
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 20, 2022
FDA Product Classification
INGREDIENTS (5)
DIPROPYLENE GLYCOLInactive
Code: E107L85C40
Classification: IACT
ESTRADIOLActive
Quantity: 0.05 mg in 1 d
Code: 4TI98Z838E
Classification: ACTIB
OLEYL ALCOHOLInactive
Code: 172F2WN8DV
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S)Inactive
Code: 83D19O7250
Classification: IACT