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FDA Approval

Increlex

CompanyEton Pharmaceuticals, Inc. (DUNS: 080870465)

Effective Date

May 7, 2025

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Mecasermin(40 mg in 4 mL)

Manufacturing Establishments (3)

Baxter Oncology GmbH

Labeler

Eton Pharmaceuticals, Inc.

DUNS Number

344276063

Tjoapack Netherlands B.V.

Labeler

Eton Pharmaceuticals, Inc.

DUNS Number

404998734

Labeler

Eton Pharmaceuticals, Inc.

DUNS Number

030606222

Products (1)

Increlex

NDC Product Code

71863-216

Application Number

BLA021839

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS

Effective Date

May 7, 2025

Ingredients

MecaserminActive

Code: 7GR9I2683OClass: ACTIBQuantity: 40 mg in 4 mL

BENZYL ALCOHOLInactive

Code: LKG8494WBHClass: IACTQuantity: 36 mg in 4 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

POLYSORBATE 20Inactive

Code: 7T1F30V5YHClass: IACT

SODIUM ACETATEInactive

Code: 4550K0SC9BClass: IACT

ACETIC ACIDInactive

Code: Q40Q9N063PClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

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