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02 1Albemarle Corporation
03 1Angene International
04 1Cambrex Corporation
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06 2Pfizer Inc
07 1Quimica Sintetica
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GDUFA
DMF Review : Reviewed
Rev. Date : 2020-07-24
Pay. Date : 2020-01-13
DMF Number : 5584
Submission : 1984-11-13
Status : Active
Type : II
NDC Package Code : 22568-1018
Start Marketing Date : 2021-06-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 22795
Submission : 2009-03-23
Status : Active
Type : II
NDC Package Code : 63126-301
Start Marketing Date : 2009-03-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : N/A
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DMF Number : 5741
Submission : 1985-03-11
Status : Inactive
Type : II
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GDUFA
DMF Review : N/A
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DMF Number : 3709
Submission : 1980-02-01
Status : Inactive
Type : II
GDUFA
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DMF Number : 8144
Submission : 1989-07-26
Status : Inactive
Type : II
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DMF Number : 6871
Submission : 1987-03-13
Status : Inactive
Type : II
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