01 1CERLIPONASE ALFA
02 1ELOSULFASE ALFA
03 1GALSULFASE
04 1LARONIDASE
05 3PEGVALIASE-PQPZ
06 3SAPROPTERIN DIHYDROCHLORIDE
07 3VOSORITIDE
01 1INJECTABLE; INJECTION
02 5INJECTABLE;INJECTION
03 2POWDER;ORAL
04 3POWDER;SUBCUTANEOUS
05 1TABLET;ORAL
06 1VIAL
01 10.4MG/VIAL
02 10.56MG/VIAL
03 11.2MG/VIAL
04 1100MG
05 1100MG/PACKET
06 110MG/0.5ML
07 12.5MG/O.5ML
08 12.9MG/ML
09 120MG/ML
10 130MG/ML
11 1500MG/PACKET
12 25MG/5ML
01 6RX
02 7Blank
RLD :
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : BRINEURA
Dosage Strength : 30MG/ML
Approval Date :
Application Number : 761052
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : VIMIZIM
Dosage Strength : 5MG/5ML
Approval Date :
Application Number : 125460
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : NAGLAZYME
Dosage Strength : 5MG/5ML
Approval Date :
Application Number : 125117
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Dosage Form : VIAL
Proprietary Name : ALDURAZYME
Dosage Strength : 2.9MG/ML
Approval Date :
Application Number : 125058
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : PALYNZIQ
Dosage Strength : 2.5MG/O.5ML
Approval Date :
Application Number : 761079
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : PALYNZIQ
Dosage Strength : 10MG/0.5ML
Approval Date :
Application Number : 761079
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : PALYNZIQ
Dosage Strength : 20MG/ML
Approval Date :
Application Number : 761079
RX/OTC/DISCN :
RLD :
TE Code :
RLD : Yes
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : KUVAN
Dosage Strength : 100MG
Approval Date : 2007-12-13
Application Number : 22181
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
Dosage Form : POWDER; ORAL
Proprietary Name : KUVAN
Dosage Strength : 100MG/PACKET
Approval Date : 2013-12-19
Application Number : 205065
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
Dosage Form : POWDER; ORAL
Proprietary Name : KUVAN
Dosage Strength : 500MG/PACKET
Approval Date : 2015-10-27
Application Number : 205065
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
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