01 5GE HEALTHCARE
02 5GUERBET
03 5HAINAN POLY
04 5HENGRUI PHARMA
01 20SOLUTION;INTRAVENOUS
01 20RX
01 5CLARISCAN
02 5DOTAREM
03 10GADOTERATE MEGLUMINE
01 15No
02 5Yes
RLD : No
TE Code : AP
Brand Name : CLARISCAN
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 3.769GM/10ML (376.9MG/ML)
Approval Date : 2019-11-01
Application Number : 210016
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : CLARISCAN
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 5.6535GM/15ML (376.9MG/ML)
Approval Date : 2019-11-01
Application Number : 210016
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : CLARISCAN
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 7.538GM/20ML (376.9MG/ML)
Approval Date : 2019-11-01
Application Number : 210016
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : CLARISCAN
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 37.69GM/100ML (376.9MG/ML)
Approval Date : 2020-08-04
Application Number : 210016
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : CLARISCAN
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 1.8845GM/5ML (376.9MG/ML)
Approval Date : 2020-11-24
Application Number : 210016
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : DOTAREM
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 37.69GM/100ML (376.9MG/ML)
Approval Date : 2013-03-20
Application Number : 204781
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : DOTAREM
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 3.769GM/10ML (376.9MG/ML)
Approval Date : 2013-03-20
Application Number : 204781
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : DOTAREM
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 5.6535GM/15ML (376.9MG/ML)
Approval Date : 2013-03-20
Application Number : 204781
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : DOTAREM
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 7.538GM/20ML (376.9MG/ML)
Approval Date : 2013-03-20
Application Number : 204781
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : DOTAREM
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 1.8845GM/5ML (376.9MG/ML)
Approval Date : 2017-03-31
Application Number : 204781
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
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