01 1Archimica
02 1Cambrex Corporation
03 1Menadiona
04 1ORGAMOL PHARMA SOLUTIONS SA
05 1Posh Chemicals P. Ltd
06 1Valens Molecules
07 1Virchow Group
08 1Blank
01 3India
02 1Italy
03 1Spain
04 1Switzerland
05 1U.S.A
06 1Blank
01 3Active
02 2Inactive
03 3Blank
01 8Blank
01 8Blank
01 1WC-235
02 7Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6658
Submission : 1986-10-29
Status : Active
Type : II
NDC Package Code : 55512-0001
Start Marketing Date : 2009-09-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-10-08
Pay. Date : 2021-08-27
DMF Number : 26127
Submission : 2012-06-05
Status : Active
Type : II
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DMF Number : 2239
Submission : 1974-03-01
Status : Active
Type : II
GDUFA
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DMF Number : 4091
Submission : 1981-03-04
Status : Inactive
Type : II
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GDUFA
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DMF Number : 6347
Submission : 1986-05-19
Status : Inactive
Type : II
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Date of Issue : 2019-11-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-235
Address of the Firm :
NDC Package Code : 62705-0220
Start Marketing Date : 2017-01-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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