Synopsis
Synopsis
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CEP/COS
0
JDMF
0
EU WC
0
NDC API
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VMF
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EDQM
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USP
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JP
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Others
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Europe
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Australia
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
US Medicaid
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Annual Reports
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Regulatory FDF Prices
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37450
Submission : 2022-08-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-01-26
Pay. Date : 2015-08-07
DMF Number : 29336
Submission : 2015-04-27
Status : Active
Type : II
Iodized oil (iodinated fatty acid ethyl ester derived from poppy seeds)
Registrant Name : Dongkook Pharmaceutical Co., Ltd.
Registration Date : 2020-02-03
Registration Number : 20200203-210-J-549
Manufacturer Name : Shanghai Wonder Pharmaceutic...
Manufacturer Address : No.298, Huachuang Road, Jinshan District, Shanghai, 201512, China
Iodized oil (iodinated fatty acid ethyl ester derived from poppy seeds)
Registrant Name : Sampoong Finechem Co., Ltd.
Registration Date : 2021-10-18
Registration Number : 20200203-210-J-549(1)
Manufacturer Name : Shanghai Wonder Pharmaceutic...
Manufacturer Address : No.298, Huachuang Road, Jinshan District, Shanghai, 201512, China
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
RLD : Yes
TE Code :
Brand Name : LIPIODOL
Dosage Form : OIL;INTRALYMPHATIC, INTRAUTERINE
Dosage Strength : EQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)
Approval Date : 1982-01-01
Application Number : 9190
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
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