01 1BRISTOL-MYERS
02 1FRESENIUS KABI USA
03 2TEVA PHARMS USA INC
01 2POWDER;INTRAVENOUS
02 2SOLUTION;INTRAVENOUS
01 2DISCN
02 2RX
01 1ISTODAX
02 3ROMIDEPSIN
01 1No
02 3Yes
RLD : Yes
TE Code : AP
Brand Name : ISTODAX
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 10MG/VIAL
Approval Date : 2009-11-05
Application Number : 22393
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : No
TE Code : AP
Brand Name : ROMIDEPSIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 10MG/VIAL
Approval Date : 2021-10-12
Application Number : 206254
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : Yes
TE Code :
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Dosage Strength : 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2020-03-13
Application Number : 208574
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
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Dosage Strength : 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2020-03-13
Application Number : 208574
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
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