Synopsis
Synopsis
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EU WC
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KDMF
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS
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US Patents
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FDF
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HRV Pharma - Market Expansion Leader in Pharmaceuticals.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41932
Submission : 2025-05-28
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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 : 2026-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
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
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 : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : 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 : 2026-12-31
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...
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