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01 4NITISINONE
02 1SODIUM PHENYLBUTYRATE
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01 4CAPSULE;ORAL
02 1PELLETS;ORAL
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01 110MG
02 120MG
03 12MG
04 15MG
05 184GM/BOT
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01 5RX
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RLD : No
TE Code : AB
Dosage Form : CAPSULE; ORAL
Proprietary Name : NITISINONE
Dosage Strength : 2MG
Approval Date : 2022-05-26
Application Number : 212390
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : CAPSULE; ORAL
Proprietary Name : NITISINONE
Dosage Strength : 5MG
Approval Date : 2022-05-26
Application Number : 212390
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : CAPSULE; ORAL
Proprietary Name : NITISINONE
Dosage Strength : 10MG
Approval Date : 2022-05-26
Application Number : 212390
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : CAPSULE; ORAL
Proprietary Name : NITISINONE
Dosage Strength : 20MG
Approval Date : 2023-04-27
Application Number : 212390
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : Yes
TE Code :
Dosage Form : PELLETS; ORAL
Proprietary Name : PHEBURANE
Dosage Strength : 84GM/BOT
Approval Date : 2022-06-17
Application Number : 216513
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
