Manufacturing Establishments (1)
Caplin Steriles Limited
Caplin Steriles Limited
650744670
Products (2)
Labetalol Hydrochloride
65145-124
ANDA214533
ANDA (C73584)
INTRAVENOUS
September 15, 2021
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 0.8 mg in 1 mL
LabetalolActive
Code: 1GEV3BAW9JClass: ACTIBQuantity: 5 mg in 1 mL
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OKClass: IACTQuantity: 45 mg in 1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.1 mg in 1 mL
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACTQuantity: 0.1 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Labetalol Hydrochloride
65145-125
ANDA214533
ANDA (C73584)
INTRAVENOUS
September 15, 2021
LabetalolActive
Code: 1GEV3BAW9JClass: ACTIBQuantity: 5 mg in 1 mL
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACTQuantity: 0.1 mg in 1 mL
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 0.8 mg in 1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.1 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OKClass: IACTQuantity: 45 mg in 1 mL