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FDA Approval

Xeomin

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Merz Pharmaceuticals, LLC
DUNS: 126209282
Effective Date
September 14, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Botulinum toxin type A(100 [USP'U] in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Merz Pharma GmbH & Co. KGaA

Merz Pharmaceuticals, LLC

342543051

Products5

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

Xeomin

Product Details

NDC Product Code
0259-1610
Application Number
BLA125360
Marketing Category
BLA (C73585)
Route of Administration
INTRAMUSCULAR
Effective Date
September 14, 2023
Albumin HumanInactive
Code: ZIF514RVZRClass: IACT
Botulinum toxin type AActive
Code: E211KPY694Class: ACTIBQuantity: 100 [USP'U] in 1 1
SucroseInactive
Code: C151H8M554Class: IACT

Xeomin

Product Details

NDC Product Code
0259-1605
Application Number
BLA125360
Marketing Category
BLA (C73585)
Route of Administration
INTRAMUSCULAR
Effective Date
September 14, 2023
Botulinum toxin type AActive
Code: E211KPY694Class: ACTIBQuantity: 50 [USP'U] in 1 1
Albumin HumanInactive
Code: ZIF514RVZRClass: IACT
SucroseInactive
Code: C151H8M554Class: IACT

Xeomin

Product Details

NDC Product Code
0259-1620
Application Number
BLA125360
Marketing Category
BLA (C73585)
Route of Administration
INTRAMUSCULAR
Effective Date
September 14, 2023
Albumin HumanInactive
Code: ZIF514RVZRClass: IACT
SucroseInactive
Code: C151H8M554Class: IACT
Botulinum toxin type AActive
Code: E211KPY694Class: ACTIBQuantity: 200 [USP'U] in 1 1

Xeomin

Product Details

NDC Product Code
0259-4110
Application Number
BLA125360
Marketing Category
BLA (C73585)
Route of Administration
INTRAMUSCULAR
Effective Date
September 14, 2023
SucroseInactive
Code: C151H8M554Class: IACT
Botulinum toxin type AActive
Code: E211KPY694Class: ACTIBQuantity: 100 [USP'U] in 1 1
Albumin HumanInactive
Code: ZIF514RVZRClass: IACT

Xeomin

Product Details

NDC Product Code
0259-4150
Application Number
BLA125360
Marketing Category
BLA (C73585)
Route of Administration
INTRAMUSCULAR
Effective Date
September 14, 2023
Botulinum toxin type AActive
Code: E211KPY694Class: ACTIBQuantity: 50 [USP'U] in 1 1
SucroseInactive
Code: C151H8M554Class: IACT
Albumin HumanInactive
Code: ZIF514RVZRClass: IACT
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