01 1Bayer AG
02 1Buchler GmbH
03 1Forest Laboratories
04 1Island Pharmaceuticals
05 1PT Sinkona
06 1Roche Diagnostics GmbH
07 2Blank
01 1Australia
02 3Germany
03 1Indonesia
04 1U.S.A
05 2Blank
01 1Active
02 7Inactive
01 8Blank
01 8Blank
01 8Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-15
Pay. Date : 2018-08-10
DMF Number : 32527
Submission : 2018-03-23
Status : Active
Type : II
NDC Package Code : 12065-1702
Start Marketing Date : 1983-01-20
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 : 3697
Submission : 1980-01-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3355
Submission : 1978-10-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5904
Submission : 1985-07-01
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 : 2723
Submission : 1976-08-05
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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 : 7292
Submission : 1988-01-15
Status : Inactive
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 : 12334
Submission : 1997-01-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5062
Submission : 1983-07-14
Status : Inactive
Type : II
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