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CPhI North America CPhI North America
Industry Trade Show
Not Confirmed
20-22 May, 2025
Drug Discovery Chemist...Drug Discovery Chemistry
Industry Trade Show
Not Confirmed
14-17 April, 2025
Pharma Live ExpoPharma Live Expo
Industry Trade Show
Not Confirmed
17-19 April, 2025
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03 Feb 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218966
14 Oct 2021
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214363
20 Aug 2020
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212957
18 Jan 2019
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211251
14 Sep 2018
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210179
28 Nov 2017
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206071
Regulatory Info : RX
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : BENZTROPINE MESYLATE
Dosage Strength : 1MG/ML
Packaging :
Approval Date : 2013-02-05
Application Number : 91525
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET, FOR SUSPENSION;O...
Brand Name : CARGLUMIC ACID
Dosage Strength : 200MG
Packaging :
Approval Date : 2022-06-22
Application Number : 213395
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : CARMUSTINE
Dosage Strength : 100MG/VIAL
Packaging :
Approval Date : 2018-09-11
Application Number : 210179
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : FOR SUSPENSION;ORAL
Brand Name : FAMOTIDINE
Dosage Strength : 40MG/5ML
Packaging :
Approval Date : 2010-05-27
Application Number : 91020
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : FOMEPIZOLE
Dosage Strength : 1.5GM/1.5ML (1GM/ML)
Packaging :
Approval Date : 2008-03-06
Application Number : 78537
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : POWDER;INTRAVENOUS
Brand Name : FOSAPREPITANT DIMEGLUMINE
Dosage Strength : EQ 150MG BASE/VIAL
Packaging :
Approval Date : 2020-08-20
Application Number : 212957
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : HYDRALAZINE HYDROCHLORIDE
Dosage Strength : 20MG/ML
Packaging :
Approval Date : 2013-03-28
Application Number : 202938
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : INDOMETHACIN SODIUM
Dosage Strength : EQ 1MG BASE/VIAL
Packaging :
Approval Date : 2017-07-19
Application Number : 206561
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : SOLUTION;IM-IV
Brand Name : METHOCARBAMOL
Dosage Strength : 1GM/10ML (100MG/ML)
Packaging :
Approval Date : 2017-11-24
Application Number : 206071
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : USA
Dosage Form : CAPSULE;ORAL
Brand Name : MIGLUSTAT
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number : 219111
Regulatory Info :
Registration Country : USA
RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : BENZTROPINE MESYLATE
Dosage Strength : 1MG/ML
Approval Date : 2013-02-05
Application Number : 91525
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AB
Dosage Form : TABLET, FOR SUSPENSION; ORAL
Proprietary Name : CARGLUMIC ACID
Dosage Strength : 200MG
Approval Date : 2022-06-22
Application Number : 213395
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : CARMUSTINE
Dosage Strength : 100MG/VIAL
Approval Date : 2018-09-11
Application Number : 210179
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AB
Dosage Form : FOR SUSPENSION; ORAL
Proprietary Name : FAMOTIDINE
Dosage Strength : 40MG/5ML
Approval Date : 2010-05-27
Application Number : 91020
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : FOMEPIZOLE
Dosage Strength : 1.5GM/1.5ML (1GM/ML)
Approval Date : 2008-03-06
Application Number : 78537
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code :
Dosage Form : POWDER; INTRAVENOUS
Proprietary Name : FOSAPREPITANT DIMEGLUMIN...
Dosage Strength : EQ 150MG BASE/VIAL
Approval Date : 2020-08-20
Application Number : 212957
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : HYDRALAZINE HYDROCHLORID...
Dosage Strength : 20MG/ML
Approval Date : 2013-03-28
Application Number : 202938
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : INDOMETHACIN SODIUM
Dosage Strength : EQ 1MG BASE/VIAL
Approval Date : 2017-07-19
Application Number : 206561
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Dosage Form : SOLUTION; IM-IV
Proprietary Name : METHOCARBAMOL
Dosage Strength : 1GM/10ML (100MG/ML)
Approval Date : 2017-11-24
Application Number : 206071
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD :
TE Code :
Dosage Form : CAPSULE; ORAL
Proprietary Name : MIGLUSTAT
Dosage Strength : 100MG
Approval Date :
Application Number : 219111
RX/OTC/DISCN :
RLD :
TE Code :
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