Synopsis
Synopsis
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KDMF
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VMF
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FDF
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Australia
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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News #PharmaBuzz
US Medicaid
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Annual Reports
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Finished Drug Prices
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GDUFA
DMF Review : Reviewed
Rev. Date : 2018-10-18
Pay. Date : 2018-09-27
DMF Number : 20538
Submission : 2007-05-11
Status : Active
Type : II
NDC Package Code : 17353-0123
Start Marketing Date : 2011-04-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-23
Pay. Date : 2021-12-14
DMF Number : 36568
Submission : 2021-12-29
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-10-19
Pay. Date : 2022-10-11
DMF Number : 30429
Submission : 2016-09-16
Status : Active
Type : II
NDC Package Code : 52221-110
Start Marketing Date : 2015-07-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-11
Pay. Date : 2012-11-28
DMF Number : 15421
Submission : 2000-01-25
Status : Active
Type : II
NDC Package Code : 12785-0779
Start Marketing Date : 1997-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19008
Submission : 2005-12-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4626
Submission : 1982-07-30
Status : Inactive
Type : II
Registration Number : 221MF10290
Registrant's Address : 3-10-4 Nihonbashi Ningyocho, Chuo-ku, Tokyo
Initial Date of Registration : 2009-12-25
Latest Date of Registration : --
NDC Package Code : 12785-0779
Start Marketing Date : 1997-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14973
Submission : 2000-07-27
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-162 - Rev 00
Issue Date : 2010-09-14
Type : Chemical
Substance Number : 569
Status : Withdrawn by EDQM F...
GDUFA
DMF Review : Complete
Rev. Date : 2018-10-18
Pay. Date : 2018-09-27
DMF Number : 20538
Submission : 2007-05-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-10-19
Pay. Date : 2022-10-11
DMF Number : 30429
Submission : 2016-09-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14973
Submission : 2000-07-27
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-23
Pay. Date : 2021-12-14
DMF Number : 36568
Submission : 2021-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19008
Submission : 2005-12-02
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-11
Pay. Date : 2012-11-28
DMF Number : 15421
Submission : 2000-01-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4626
Submission : 1982-07-30
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-162 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2010-09-14
Type : Chemical
Substance Number : 569
Registration Number : 221MF10290
Registrant's Address : 3-10-4 Nihonbashi Ningyocho, Chuo-ku, Tokyo
Initial Date of Registration : 2009-12-25
Latest Date of Registration : 2015-08-31
NDC Package Code : 17353-0123
Start Marketing Date : 2011-04-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 17353-0123
Start Marketing Date : 2011-04-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 52221-110
Start Marketing Date : 2015-07-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 12785-0779
Start Marketing Date : 1997-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
About the Company : Conscientia Industrial is a pharmaceutical company, mainly developing, manufacturing, marketing APIs (Active Pharmaceutical Ingredients), intermediates, fine chemicals in China. We...
About the Company : Xieli is an EU GMP\ Japan GMP\ Chinese GMP certified manufacturer of Botanical derivative APIs and Oncology APIs from China.A leading producer of Rutin, Troxerutin, Diosmin, Artemi...
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Protamine Sulphate Injection B.P.
Dosage Form : INJ
Dosage Strength : 50mg/5ml
Packaging : 5X10mg/5ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 10MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 10MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : DISCN
Registration Country : USA
Brand Name : PROTAMINE SULFATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/ML
Packaging :
Approval Date : 1986-11-05
Application Number : 89474
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : Protaminsulfat LEO Pharma
Dosage Form : INJEKTIONS-/INFUSIONSVÄTSKA, LÖSNING
Dosage Strength : 1400 ANTI-HEPARIN IE/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Protamine sulphate LEO Pharma
Dosage Form : INJEKTIONS-/INFUSIONSVÄTSKA, LÖSNING
Dosage Strength : 1400 ANTI-HEPARIN IE/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info : DISCN
Registration Country : USA
Brand Name : PROTAMINE SULFATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 1982-01-01
Application Number : 7413
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : PROTAMINE SULFATE
Dosage Form : Injectable; Injection
Dosage Strength : 10MG/ML
Packaging :
Approval Date :
Application Number : 89306
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : Canada
Brand Name : PROTAMINE SULFATE INJECTION USP
Dosage Form : SOLUTION
Dosage Strength : 10MG/ML
Packaging : 10X5ML, 1X25ML
Approval Date :
Application Number : 2231674
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Sweden
Brand Name : Protaminsulfat LEO Pharma
Dosage Form : INJEKTIONS-/INFUSIONSVÄTSKA, LÖSNING
Dosage Strength : 1400 ANTI-HEPARIN IE/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
RLD : Yes
TE Code :
Brand Name : PROTAMINE SULFATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1982-01-01
Application Number : 6460
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : PROTAMINE SULFATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/ML
Approval Date : 1987-04-07
Application Number : 89454
RX/OTC/DISCN : RX
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : PROTAMINE SULFATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/ML
Approval Date : 1986-11-05
Application Number : 89474
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : PROTAMINE SULFATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/ML
Approval Date : 1986-11-05
Application Number : 89475
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : PROTAMINE SULFATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 50MG/VIAL
Approval Date : 1982-01-01
Application Number : 7413
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : PROTAMINE SULFATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MG/VIAL
Approval Date : 1984-08-02
Application Number : 7413
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD :
TE Code :
Brand Name : PROTAMINE SULFATE
Dosage Form : Injectable; Injection
Dosage Strength : 10MG/ML
Approval Date :
Application Number : 89306
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : PROTAMINE SULFATE
Dosage Form : Injectable; Injection
Dosage Strength : 50MG/VIAL
Approval Date :
Application Number : 89307
RX/OTC/DISCN :
RLD :
TE Code :
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