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ELIGARD

These highlights do not include all the information needed to use ELIGARD safely and effectively. See full prescribing information for ELIGARD. ELIGARD (leuprolide acetate) for injectable suspension, for subcutaneous use Initial U.S. Approval: 2002

Approved
Approval ID

b78d1919-9dee-44fa-90f9-e0a26d32481d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 29, 2019

Manufacturers
FDA

TOLMAR Inc.

DUNS: 791156578

Products 4

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

Leuprolide Acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62935-453
Application NumberNDA021731
Product Classification
M
Marketing Category
C73594
G
Generic Name
Leuprolide Acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateApril 29, 2019
FDA Product Classification

Leuprolide Acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62935-753
Application NumberNDA021343
Product Classification
M
Marketing Category
C73594
G
Generic Name
Leuprolide Acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateApril 29, 2019
FDA Product Classification

Leuprolide Acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62935-303
Application NumberNDA021488
Product Classification
M
Marketing Category
C73594
G
Generic Name
Leuprolide Acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateApril 29, 2019
FDA Product Classification

Leuprolide Acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62935-223
Application NumberNDA021379
Product Classification
M
Marketing Category
C73594
G
Generic Name
Leuprolide Acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateApril 29, 2019
FDA Product Classification

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ELIGARD - FDA Drug Approval Details