01 1Amphastar Pharmaceuticals
02 1Novo Excipients
03 1Blank
01 1India
02 1U.S.A
03 1Blank
01 3Active
01 3Blank
01 3Blank
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32700
Submission : 2018-05-16
Status : Active
Type : II
NDC Package Code : 52221-115
Start Marketing Date : 2015-08-25
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
Rev. Date :
Pay. Date :
DMF Number : 39605
Submission : 2024-03-14
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27184
Submission : 2013-05-15
Status : Active
Type : IV
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