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CPhI WW FrankfurtCPhI WW Frankfurt
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28-30 October, 2025
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26-29 October, 2025
ISPE Annual MeetingISPE Annual Meeting
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26-29 October, 2025
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Events
Webinars & Exhibitions
CPhI WW FrankfurtCPhI WW Frankfurt
Industry Trade Show
Not Confirmed
28-30 October, 2025
Industry Trade Show
Not Confirmed
26-29 October, 2025
ISPE Annual MeetingISPE Annual Meeting
Industry Trade Show
Not Confirmed
26-29 October, 2025
Digital content
INTERVIEW #SpeakPharma
[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/we-re-expanding-our-cdmo-capabilities-to-meet-the-next-wave-of-complex-therapies-starting-with-oncology
VLOG #PharmaReel
[Sponsored by another company]DATA COMPILATION #PharmaFlow
[Sponsored by another company]https://www.pharmacompass.com/radio-compass-blog/cdmo-activity-tracker-veranova-chemexpress-invest-in-adc-facilities-cohance-to-set-up-oligonucleotide-facility-in-india

15 Oct 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214023

02 Jul 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218032

27 Aug 2024
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214732

22 Aug 2024
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218410
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=090541
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213444
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Regulatory Info : RX
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Dosage Form : CAPSULE;ORAL
Brand Name : BUTALBITAL, ACETAMINOPHEN...
Dosage Strength : 300MG;50MG;40MG
Packaging :
Approval Date : 2021-11-17
Application Number : 215047
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : CAPSULE, EXTENDED RELEAS...
Brand Name : ACETAZOLAMIDE
Dosage Strength : 500MG
Packaging :
Approval Date : 2016-09-30
Application Number : 203434
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : AMPHETAMINE SULFATE
Dosage Strength : 5MG
Packaging :
Approval Date : 2020-08-24
Application Number : 213763
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : AMPHETAMINE SULFATE
Dosage Strength : 10MG
Packaging :
Approval Date : 2020-08-24
Application Number : 213763
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : ARSENIC TRIOXIDE
Dosage Strength : 1MG/ML
Packaging :
Approval Date : 2018-11-15
Application Number : 209315
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : ARSENIC TRIOXIDE
Dosage Strength : 2MG/ML
Packaging :
Approval Date : 2021-01-14
Application Number : 209315
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : CARISOPRODOL AND ASPIRIN
Dosage Strength : 325MG;200MG
Packaging :
Approval Date : 2010-01-07
Application Number : 40832
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Dosage Form : AEROSOL, FOAM;TOPICAL
Brand Name : BETAMETHASONE VALERATE
Dosage Strength : 0.12%
Packaging :
Approval Date : 2017-05-24
Application Number : 207144
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
Dosage Form : CAPSULE;ORAL
Brand Name : BISMUTH SUBCITRATE POTASS...
Dosage Strength : 140MG;125MG;125MG
Packaging :
Approval Date : 2023-07-03
Application Number : 217511
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET, EXTENDED RELEASE...
Brand Name : CARBAMAZEPINE
Dosage Strength : 100MG
Packaging :
Approval Date : 2022-12-02
Application Number : 216404
Regulatory Info : RX
Registration Country : USA

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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RLD : No
TE Code : AA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Dosage Form : CAPSULE; ORAL
Proprietary Name : BUTALBITAL, ACETAMINOPHE...
Dosage Strength : 300MG;50MG;40MG
Approval Date : 2021-11-17
Application Number : 215047
RX/OTC/DISCN : RX
RLD : No
TE Code : AA

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RLD : No
TE Code : AB
Dosage Form : CAPSULE, EXTENDED RELEASE; ORA...
Proprietary Name : ACETAZOLAMIDE
Dosage Strength : 500MG
Approval Date : 2016-09-30
Application Number : 203434
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : AMPHETAMINE SULFATE
Dosage Strength : 5MG
Approval Date : 2020-08-24
Application Number : 213763
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : AMPHETAMINE SULFATE
Dosage Strength : 10MG
Approval Date : 2020-08-24
Application Number : 213763
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : ARSENIC TRIOXIDE
Dosage Strength : 1MG/ML
Approval Date : 2018-11-15
Application Number : 209315
RX/OTC/DISCN : RX
RLD : No
TE Code : AP

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RLD : No
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : ARSENIC TRIOXIDE
Dosage Strength : 2MG/ML
Approval Date : 2021-01-14
Application Number : 209315
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : CARISOPRODOL AND ASPIRIN
Dosage Strength : 325MG;200MG
Approval Date : 2010-01-07
Application Number : 40832
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code :
Dosage Form : AEROSOL, FOAM; TOPICAL
Proprietary Name : BETAMETHASONE VALERATE
Dosage Strength : 0.12%
Approval Date : 2017-05-24
Application Number : 207144
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code : AB
BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
Dosage Form : CAPSULE; ORAL
Proprietary Name : BISMUTH SUBCITRATE POTAS...
Dosage Strength : 140MG;125MG;125MG
Approval Date : 2023-07-03
Application Number : 217511
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : CARBAMAZEPINE
Dosage Strength : 100MG
Approval Date : 2022-12-02
Application Number : 216404
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

Inspections and registrations
District Decision : No Action Indicated
Inspection End Date : 2015-06-05
City : Nantong
State :
Country/Area : China
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2015-06-05

District Decision : No Action Indicated
Inspection End Date : 2013-03-29
City : Nantong
State :
Country/Area : China
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2013-03-29

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Manufacturer :
FDF Manufacturer : FDF MANUFACTURE
Facility Name : Novast Laboratories Ltd.
Business Address : 1 Guangxing Road, Free Trade...
FEI Number : 3006346108
Country : China
Paid in : 2019

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE