Registrants (1)
Hainan Poly Pharm. Co., Ltd.
654561638
Manufacturing Establishments (1)
Hainan Poly Pharm. Co., Ltd.
Hainan Poly Pharm. Co., Ltd.
Hainan Poly Pharm. Co., Ltd.
654561638
Products (2)
Dobutamine
14335-171
ANDA216131
ANDA (C73584)
INTRAVENOUS
January 2, 2023
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACTQuantity: 0.2 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
DobutamineActive
Code: 0WR771DJXVClass: ACTIMQuantity: 12.5 mg in 1 mL
Dobutamine
14335-172
ANDA216131
ANDA (C73584)
INTRAVENOUS
January 2, 2023
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACTQuantity: 0.2 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
DobutamineActive
Code: 0WR771DJXVClass: ACTIMQuantity: 12.5 mg in 1 mL