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23-24 March, 2026
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PBP World MeetingPBP World Meeting
Industry Trade Show
Not Confirmed
23-26 March, 2026
Industry Trade Show
Not Confirmed
23-24 March, 2026
European Pharma Congre...European Pharma Congress
Industry Trade Show
Not Confirmed
23-24 March, 2026
Digital content

05 Mar 2026
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220239

25 Feb 2026
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220335

14 Jan 2026
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219440

10 Oct 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216678

08 Oct 2025
// EXPRESSPHARMA
https://www.expresspharma.in/general-atlantic-singapore-transfers-3-49-million-rubicon-research-shares-ahead-of-ipo/

22 Sep 2025
// EXPRESSPHARMA
https://www.expresspharma.in/rubicon-research-receives-rs-140-cr-fund-from-timf-holdings-360-one/
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27347
Submission : 2013-09-03
Status : Active
Type : II

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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAZOLAMIDE
Dosage Strength : 125MG
Approval Date : 2021-08-19
Application Number : 215101
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAZOLAMIDE
Dosage Strength : 250MG
Approval Date : 2021-08-19
Application Number : 215101
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : SUSPENSION; ORAL
Proprietary Name : ACYCLOVIR
Dosage Strength : 200MG/5ML
Approval Date : 2022-08-18
Application Number : 215724
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : CAPSULE; ORAL
Proprietary Name : AMANTADINE HYDROCHLORIDE
Dosage Strength : 100MG
Approval Date : 2020-05-21
Application Number : 212044
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : AMIODARONE HYDROCHLORIDE
Dosage Strength : 200MG
Approval Date : 2008-11-06
Application Number : 78578
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : AMIODARONE HYDROCHLORIDE
Dosage Strength : 100MG
Approval Date : 2021-02-26
Application Number : 78578
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : AMIODARONE HYDROCHLORIDE
Dosage Strength : 400MG
Approval Date : 2021-02-26
Application Number : 78578
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : BX
Dosage Form : TABLET; ORAL
Proprietary Name : AMITRIPTYLINE HYDROCHLOR...
Dosage Strength : 10MG
Approval Date : 2023-05-01
Application Number : 215376
RX/OTC/DISCN : RX
RLD : No
TE Code : BX

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RLD : No
TE Code : BX
Dosage Form : TABLET; ORAL
Proprietary Name : AMITRIPTYLINE HYDROCHLOR...
Dosage Strength : 25MG
Approval Date : 2023-05-01
Application Number : 215376
RX/OTC/DISCN : RX
RLD : No
TE Code : BX

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RLD : No
TE Code : BX
Dosage Form : TABLET; ORAL
Proprietary Name : AMITRIPTYLINE HYDROCHLOR...
Dosage Strength : 50MG
Approval Date : 2023-05-01
Application Number : 215376
RX/OTC/DISCN : RX
RLD : No
TE Code : BX

District Decision : No Action Indicated
Inspection End Date : 2025-03-20
City : Thane
State :
Country/Area : India
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2025-03-20

District Decision : No Action Indicated
Inspection End Date : 2024-03-08
City : Thane
State :
Country/Area : India
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2024-03-08

District Decision : No Action Indicated
Inspection End Date : 2023-11-03
City : Concord
State :
Country/Area : Canada
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2023-11-03

District Decision : Voluntary Action Indicated
Inspection End Date : 2023-01-27
City : Thane
State :
Country/Area : India
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2023-01-27

District Decision : No Action Indicated
Inspection End Date : 2018-10-18
City : Concord
State :
Country/Area : Canada
Zip :
District :
Center :
Project Area : Bioresearch Monitoring
District Decision : No Action Indicated
Inspection End Date : 2018-10-18

District Decision : No Action Indicated
Inspection End Date : 2017-11-20
City : Thane
State :
Country/Area : India
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2017-11-20

District Decision : Voluntary Action Indicated
Inspection End Date : 2016-07-27
City : Concord
State :
Country/Area : Canada
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2016-07-27

District Decision : No Action Indicated
Inspection End Date : 2015-03-13
City : Thane
State :
Country/Area : India
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2015-03-13

District Decision : Voluntary Action Indicated
Inspection End Date : 2013-04-11
City : Thane
State :
Country/Area : India
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-04-11

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