Application 000552

Type
NDA
Sponsor
ORGANON USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIQUAEMIN SODIUMHEPARIN SODIUMINJECTABLE;INJECTION20,000 UNITS/MLNoNo
002LIQUAEMIN SODIUMHEPARIN SODIUMINJECTABLE;INJECTION40,000 UNITS/MLNoNo
003LIQUAEMIN SODIUMHEPARIN SODIUMINJECTABLE;INJECTION5,000 UNITS/MLNoNo
004LIQUAEMIN SODIUMHEPARIN SODIUMINJECTABLE;INJECTION1,000 UNITS/MLNoNo
005LIQUAEMIN SODIUMHEPARIN SODIUMINJECTABLE;INJECTION10,000 UNITS/MLNoNo
007LIQUAEMIN LOCK FLUSHHEPARIN SODIUMINJECTABLE;INJECTION100 UNITS/MLNoNo
008HEPARIN SODIUMHEPARIN SODIUMINJECTABLE;INJECTION1,000 UNITS/MLNoNo
009HEPARIN SODIUMHEPARIN SODIUMINJECTABLE;INJECTION5,000 UNITS/MLNoNo
010HEPARIN SODIUMHEPARIN SODIUMINJECTABLE;INJECTION10,000 UNITS/MLNoNo
011LIQUAEMIN SODIUM PRESERVATIVE FREEHEPARIN SODIUMINJECTABLE;INJECTION1,000 UNITS/MLNoNo
012LIQUAEMIN SODIUM PRESERVATIVE FREEHEPARIN SODIUMINJECTABLE;INJECTION5,000 UNITS/MLNoNo
013LIQUAEMIN SODIUM PRESERVATIVE FREEHEPARIN SODIUMINJECTABLE;INJECTION10,000 UNITS/MLNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80003SUPPL 2024-10-28
79989SUPPL 2024-10-25