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CEP/COS
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1. Dextroamphetamine Saccharate
Molecular Weight | 345.34 g/mol |
---|---|
Molecular Formula | C15H23NO8 |
Hydrogen Bond Donor Count | 7 |
Hydrogen Bond Acceptor Count | 9 |
Rotatable Bond Count | 7 |
Exact Mass | 345.14236669 g/mol |
Monoisotopic Mass | 345.14236669 g/mol |
Topological Polar Surface Area | 182 Ų |
Heavy Atom Count | 24 |
Formal Charge | 0 |
Complexity | 287 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 4 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
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 : 2024-12-31
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 : 2024-12-31
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 : 2024-12-31
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 : 2024-12-31
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
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-10
Pay. Date : 2013-04-03
DMF Number : 24071
Submission : 2010-08-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15090
Submission : 2000-10-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-11
Pay. Date : 2012-12-12
DMF Number : 15305
Submission : 2001-02-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-03
Pay. Date : 2013-11-21
DMF Number : 16022
Submission : 2002-06-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15608
Submission : 2001-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-08
Pay. Date : 2013-05-31
DMF Number : 15428
Submission : 2001-05-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-06
Pay. Date : 2023-08-03
DMF Number : 38543
Submission : 2023-08-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-31
Pay. Date : 2015-08-27
DMF Number : 29603
Submission : 2016-02-25
Status : Active
Type : II
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