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FDA Approval

Dobutamine

CompanySlate Run Pharmaceuticals (DUNS: 039452765)

Effective Date

February 28, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Dobutamine(250 mg in 20 mL)

Registrants (1)

Hainan Poly Pharm. Co., Ltd.

DUNS Number

654561638

Manufacturing Establishments (1)

Hainan Poly Pharm. Co., Ltd.

Labeler

Slate Run Pharmaceuticals

Registrant

Hainan Poly Pharm. Co., Ltd.

DUNS Number

654561638

Products (1)

Dobutamine

NDC Product Code

70436-203

Application Number

ANDA216131

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

February 28, 2023

Ingredients

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM METABISULFITEInactive

Code: 4VON5FNS3CClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

DobutamineActive

Code: 0WR771DJXVClass: ACTIMQuantity: 250 mg in 20 mL

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