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01 1COLESTIPOL HYDROCHLORIDE
02 1FLUNISOLIDE
03 3ISOSORBIDE MONONITRATE
04 3OXCARBAZEPINE
05 1SCOPOLAMINE
06 3SIPONIMOD
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01 1SPRAY, METERED;NASAL
02 1SYSTEM;TRANSDERMAL
03 6TABLET, EXTENDED RELEASE;ORAL
04 4TABLET;ORAL
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01 10.025MG/SPRAY
02 1120MG
03 1150MG
04 11GM
05 11MG/72HR
06 1300MG
07 130MG
08 1600MG
09 160MG
10 1EQ 0.25MG BASE
11 1EQ 1MG BASE
12 1EQ 2MG BASE
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01 3DISCN
02 9RX
RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : COLESTIPOL HYDROCHLORIDE
Dosage Strength : 1GM
Approval Date : 2024-12-03
Application Number : 217462
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : SPRAY, METERED; NASAL
Proprietary Name : FLUNISOLIDE
Dosage Strength : 0.025MG/SPRAY
Approval Date : 2022-06-16
Application Number : 207802
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : ISOSORBIDE MONONITRATE
Dosage Strength : 30MG
Approval Date : 2018-11-05
Application Number : 210918
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : ISOSORBIDE MONONITRATE
Dosage Strength : 60MG
Approval Date : 2018-11-05
Application Number : 210918
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : ISOSORBIDE MONONITRATE
Dosage Strength : 120MG
Approval Date : 2018-11-05
Application Number : 210918
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : OXCARBAZEPINE
Dosage Strength : 150MG
Approval Date : 2024-11-22
Application Number : 215796
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : OXCARBAZEPINE
Dosage Strength : 300MG
Approval Date : 2024-11-22
Application Number : 215796
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : OXCARBAZEPINE
Dosage Strength : 600MG
Approval Date : 2024-11-22
Application Number : 215796
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : SYSTEM; TRANSDERMAL
Proprietary Name : SCOPOLAMINE
Dosage Strength : 1MG/72HR
Approval Date : 2020-11-24
Application Number : 212342
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : SIPONIMOD
Dosage Strength : EQ 0.25MG BASE
Approval Date : 2025-04-22
Application Number : 218444
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
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