01 1Apotex Pharmachem
02 1Esteve Quimica
03 1Glenmark Life Sciences
04 1Glenmark Pharmaceuticals
05 1Kremers Urban Pharmaceuticals
06 1ORGAMOL PHARMA SOLUTIONS SA
01 1Canada
02 2India
03 1Spain
04 1Switzerland
05 1U.S.A
01 2Active
02 3Inactive
03 1Blank
01 6Blank
01 6Blank
01 1WC-0057n
02 5Blank
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GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 19113
Submission : 2006-01-18
Status : Active
Type : II
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DMF Number : 20426
Submission : 2007-04-09
Status : Active
Type : II
Date of Issue : 2022-06-07
Valid Till : 2025-06-25
Written Confirmation Number : WC-0057n
Address of the Firm :
NDC Package Code : 66039-838
Start Marketing Date : 2007-04-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
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DMF Number : 10520
Submission : 1993-09-30
Status : Inactive
Type : II
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DMF Number : 15172
Submission : 2000-12-06
Status : Inactive
Type : II
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DMF Number : 16670
Submission : 2003-06-25
Status : Inactive
Type : II
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