01 1Amsa Spa
02 1COSMA S.p.A
03 1Cilag AG
04 2Mallinckrodt Pharmaceuticals
05 1ORGANICA Feinchemie GmbH Wolfen
06 1Viatris
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01 1Germany
02 2Ireland
03 2Italy
04 1Switzerland
05 1U.S.A
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01 1Active
02 7Inactive
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GDUFA
DMF Review : N/A
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DMF Number : 22092
Submission : 2008-10-16
Status : Active
Type : II
NDC Package Code : 65015-717
Start Marketing Date : 2015-01-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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
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DMF Number : 7270
Submission : 1987-12-18
Status : Inactive
Type : II
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GDUFA
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DMF Number : 2763
Submission : 1976-09-27
Status : Inactive
Type : II
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DMF Number : 2790
Submission : 1976-11-10
Status : Inactive
Type : II
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DMF Number : 7336
Submission : 1988-02-05
Status : Inactive
Type : II
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DMF Number : 4109
Submission : 1981-03-23
Status : Inactive
Type : II
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DMF Number : 16432
Submission : 2003-02-17
Status : Inactive
Type : II
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DMF Number : 2537
Submission : 1975-10-21
Status : Inactive
Type : II
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