01 1Corden Pharma Bergamo S.p.A
02 1H. Lundbeck AS
03 1IIQUIAP
04 1Lupin Ltd
05 1Pisgah Labs
06 2R L Fine Chem
07 1Teva API
08 1Teva Pharmaceutical Industries
09 3Blank
01 1Denmark
02 3India
03 2Israel
04 1Italy
05 1Mexico
06 1U.S.A
07 3Blank
01 3Active
02 6Inactive
03 3Blank
01 12Blank
01 12Blank
01 1WC-0001A4
02 1WC-0201
03 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22104
Submission : 2008-10-15
Status : Active
Type : II
NDC Package Code : 45562-1127
Start Marketing Date : 2008-11-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21493
Submission : 2008-03-28
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-09-10
Written Confirmation Number : WC-0201
Address of the Firm :
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 : 5322
Submission : 1984-04-02
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 : 6763
Submission : 1986-12-23
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 : 14150
Submission : 1999-05-21
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 : 15359
Submission : 2001-03-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18801
Submission : 2005-09-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23076
Submission : 2009-08-26
Status : Inactive
Type : II
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