Veranova: A CDMO that manages complexity with confidence.
01 2Veranova
02 1Cambrex Corporation
03 1Curia
04 1ISP Freetown Fine Chemicals
05 1Mallinckrodt Pharmaceuticals
06 2Siegfried AG
01 1Ireland
02 2Switzerland
03 5U.S.A
01 7Active
02 1Inactive
01 8Blank
01 8Blank
01 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15090
Submission : 2000-10-13
Status : Active
Type : II
NDC Package Code : 49812-0060
Start Marketing Date : 1999-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : CA |
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-04-10
Pay. Date : 2013-04-03
DMF Number : 24071
Submission : 2010-08-10
Status : Active
Type : II
NDC Package Code : 49812-0060
Start Marketing Date : 1999-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : CA |
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-08
Pay. Date : 2013-05-31
DMF Number : 15428
Submission : 2001-05-15
Status : Active
Type : II
NDC Package Code : 0406-2901
Start Marketing Date : 2013-11-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-08-31
Pay. Date : 2015-08-27
DMF Number : 29603
Submission : 2016-02-25
Status : Active
Type : II
NDC Package Code : 0792-3938
Start Marketing Date : 2023-08-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-06
Pay. Date : 2023-08-03
DMF Number : 38543
Submission : 2023-08-01
Status : Active
Type : II
NDC Package Code : 0792-3938
Start Marketing Date : 2023-08-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-11
Pay. Date : 2012-12-12
DMF Number : 15305
Submission : 2001-02-26
Status : Active
Type : II
NDC Package Code : 59116-1930
Start Marketing Date : 2012-10-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-03
Pay. Date : 2013-11-21
DMF Number : 16022
Submission : 2002-06-21
Status : Active
Type : II
NDC Package Code : 65392-0115
Start Marketing Date : 2018-05-01
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 : 15608
Submission : 2001-09-01
Status : Inactive
Type : II
A Dextroamphetamine Saccharate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dextroamphetamine Saccharate, including repackagers and relabelers. The FDA regulates Dextroamphetamine Saccharate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dextroamphetamine Saccharate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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