01 2Bristol Myers Squibb
02 1Fresenius Kabi USA
03 2Teva Pharmaceutical Industries
01 1KIT
02 2POWDER;INTRAVENOUS
03 2SOLUTION;INTRAVENOUS
01 2DISCN
02 1Prescription
03 2RX
01 2ISTODAX
02 3ROMIDEPSIN
01 1Canada
02 4USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ISTODAX
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 10MG/VIAL
Packaging :
Approval Date : 2009-11-05
Application Number : 22393
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ISTODAX
Dosage Form : KIT
Dosage Strength : 10MG/VIAL
Packaging : 1
Approval Date :
Application Number : 2414295
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : RX
Registration Country : USA
Brand Name : ROMIDEPSIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 10MG/VIAL
Packaging :
Approval Date : 2021-10-12
Application Number : 206254
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ROMIDEPSIN
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2020-03-13
Application Number : 208574
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ROMIDEPSIN
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2020-03-13
Application Number : 208574
Regulatory Info : DISCN
Registration Country : USA
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