LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-29
Pay. Date : 2015-01-19
DMF Number : 22958
Submission : 2009-07-15
Status : Active
Type : II
NDC Package Code : 65015-900
Start Marketing Date : 2024-03-26
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 : 39207
Submission : 2023-12-01
Status : Active
Type : II
NDC Package Code : 65015-900
Start Marketing Date : 2024-03-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-02-03
Pay. Date : 2015-02-13
DMF Number : 21247
Submission : 2008-01-14
Status : Active
Type : II
NDC Package Code : 46016-2541
Start Marketing Date : 2004-10-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-07-25
Pay. Date : 2024-07-18
DMF Number : 22810
Submission : 2009-06-15
Status : Active
Type : II
NDC Package Code : 72643-037
Start Marketing Date : 2024-03-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-06
Pay. Date : 2013-11-06
DMF Number : 27331
Submission : 2013-11-05
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-27
Pay. Date : 2016-12-27
DMF Number : 31181
Submission : 2016-12-28
Status : Active
Type : II
NDC Package Code : 47621-054
Start Marketing Date : 2017-09-01
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 : 8304
Submission : 1989-11-24
Status : Active
Type : II
NDC Package Code : 17381-554
Start Marketing Date : 2010-04-13
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 : 22201
Submission : 2008-11-20
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 : 7267
Submission : 1987-12-29
Status : Inactive
Type : II
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