01 1Bidachem
02 2Boehringer Ingelheim GmbH
03 1Cambrex Corporation
04 1Cipla
05 1Industriale Chimica
06 1Labochem Ltd
07 1Lusochimica
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01 2Germany
02 1Greece
03 1India
04 3Italy
05 1U.S.A
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01 2Active
02 4Inactive
03 3Blank
01 1Expired
02 1Valid
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5327
Submission : 1984-03-27
Status : Active
Type : II
NDC Package Code : 43898-0106
Start Marketing Date : 1984-03-27
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 : 8129
Submission : 1989-07-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6597
Submission : 1986-09-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6835
Submission : 1987-02-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7717
Submission : 1988-10-18
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 :
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DMF Number : 7010
Submission : 1987-05-13
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : R0-CEP 2001-235 - Rev 01
Issue Date : 2004-10-13
Type : Chemical
Substance Number : 1033
Status : Expired
Certificate Number : R0-CEP 2001-236 - Rev 01
Issue Date : 2004-10-13
Type : Chemical
Substance Number : 1033
Status : Withdrawn by Holder
Certificate Number : R1-CEP 2004-217 - Rev 00
Issue Date : 2012-03-07
Type : Chemical
Substance Number : 1033
Status : Valid
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