NDC 53157-303

LEUKOSEP - SOLX A ADDITIVE SOLUTION

Sol A Additive Solution

LEUKOSEP - SOLX A ADDITIVE SOLUTION is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Haemonetics Manufacturing Inc. The primary component is Adenine; Mannitol.

Product ID53157-303_795f1082-9ede-47cb-9a22-5092787ecbb3
NDC53157-303
Product TypeHuman Prescription Drug
Proprietary NameLEUKOSEP - SOLX A ADDITIVE SOLUTION
Generic NameSol A Additive Solution
Dosage FormSolution
Route of AdministrationINTRAVENOUS
Marketing Start Date2013-05-15
Marketing CategoryNDA / NDA
Application NumberNDA110059
Labeler NameHaemonetics Manufacturing Inc
Substance NameADENINE; MANNITOL
Active Ingredient Strength30 mg/80mL; g/80mL
Pharm ClassesIncreased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53157-303-03

80 mL in 1 BAG (53157-303-03)
Marketing Start Date2013-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53157-303-03 [53157030303]

LEUKOSEP - SOLX A ADDITIVE SOLUTION SOLUTION
Marketing CategoryNDA
Application NumberNDA110059
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-05-15
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
ADENINE30 mg/80mL

Pharmacological Class

  • Increased Diuresis [PE]
  • Osmotic Activity [MoA]
  • Osmotic Diuretic [EPC]

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.