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ELEVIDYS

These highlights do not include all the information needed to use ELEVIDYS safely and effectively. See full prescribing information for ELEVIDYS. ELEVIDYS (delandistrogene moxeparvovec-rokl) suspension, for intravenous infusion Initial U.S. Approval: 2023

Approved
Approval ID

3525abcd-fbd2-46c5-9706-cffdf2e8a361

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 11, 2023

Manufacturers
FDA

Sarepta Therapeutics, Inc.

DUNS: 121653406

Products 10

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

delandistrogene moxeparvovec-rokl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60923-503
Application NumberBLA125781
Product Classification
M
Marketing Category
C73585
G
Generic Name
delandistrogene moxeparvovec-rokl
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 11, 2023
FDA Product Classification

delandistrogene moxeparvovec-rokl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60923-530
Application NumberBLA125781
Product Classification
M
Marketing Category
C73585
G
Generic Name
delandistrogene moxeparvovec-rokl
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 11, 2023
FDA Product Classification

delandistrogene moxeparvovec-rokl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60923-513
Application NumberBLA125781
Product Classification
M
Marketing Category
C73585
G
Generic Name
delandistrogene moxeparvovec-rokl
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 11, 2023
FDA Product Classification

delandistrogene moxeparvovec-rokl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60923-527
Application NumberBLA125781
Product Classification
M
Marketing Category
C73585
G
Generic Name
delandistrogene moxeparvovec-rokl
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 11, 2023
FDA Product Classification

delandistrogene moxeparvovec-rokl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60923-511
Application NumberBLA125781
Product Classification
M
Marketing Category
C73585
G
Generic Name
delandistrogene moxeparvovec-rokl
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 11, 2023
FDA Product Classification

delandistrogene moxeparvovec-rokl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60923-507
Application NumberBLA125781
Product Classification
M
Marketing Category
C73585
G
Generic Name
delandistrogene moxeparvovec-rokl
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 11, 2023
FDA Product Classification

delandistrogene moxeparvovec-rokl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60923-552
Application NumberBLA125781
Product Classification
M
Marketing Category
C73585
G
Generic Name
delandistrogene moxeparvovec-rokl
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 11, 2023
FDA Product Classification

delandistrogene moxeparvovec-rokl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60923-534
Application NumberBLA125781
Product Classification
M
Marketing Category
C73585
G
Generic Name
delandistrogene moxeparvovec-rokl
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 11, 2023
FDA Product Classification

delandistrogene moxeparvovec-rokl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60923-523
Application NumberBLA125781
Product Classification
M
Marketing Category
C73585
G
Generic Name
delandistrogene moxeparvovec-rokl
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 11, 2023
FDA Product Classification

delandistrogene moxeparvovec-rokl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60923-525
Application NumberBLA125781
Product Classification
M
Marketing Category
C73585
G
Generic Name
delandistrogene moxeparvovec-rokl
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 11, 2023
FDA Product Classification

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