01 1Actavis Inc
02 1BOC Sciences
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05 1Fison
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GDUFA
DMF Review : Reviewed
Rev. Date : 2019-06-12
Pay. Date : 2019-04-30
DMF Number : 33358
Submission : 2018-11-27
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-06-15
Pay. Date : 2015-07-28
DMF Number : 27823
Submission : 2015-06-10
Status : Active
Type : II
Date of Issue : 2020-02-10
Valid Till : 2022-02-02
Written Confirmation Number : WC-0356
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-10-20
Pay. Date : 2023-10-17
DMF Number : 8364
Submission : 1989-12-29
Status : Active
Type : II
VMF Number : 3829
Submission : 1985-02-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29214
Submission : 2015-03-20
Status : Active
Type : II
NDC Package Code : 12666-0020
Start Marketing Date : 2011-12-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12295
Submission : 1996-12-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3774
Submission : 1980-03-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1601
Submission : 1970-10-26
Status : Inactive
Type : II
VMF Number : 3829
Submission : 1985-02-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8808
Submission : 1990-10-31
Status : Inactive
Type : II
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 : 7608
Submission : 1988-07-28
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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 : 10075
Submission : 1993-02-05
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Iron Dextran manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iron Dextran, including repackagers and relabelers. The FDA regulates Iron Dextran manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iron Dextran API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Iron Dextran manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Iron Dextran supplier is an individual or a company that provides Iron Dextran active pharmaceutical ingredient (API) or Iron Dextran finished formulations upon request. The Iron Dextran suppliers may include Iron Dextran API manufacturers, exporters, distributors and traders.
click here to find a list of Iron Dextran suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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