01 1Alembic Pharmaceuticals Limited
02 1Cambrex Corporation
03 1Centaur Pharmaceuticals
04 1F.I.S. Fabbrica Italiana Sintetici
05 1R L Fine Chem
06 1Sandoz B2B
07 1Viatris
08 1Wyeth Pharmaceuticals Inc
09 1Blank
01 3India
02 1Italy
03 1Switzerland
04 3U.S.A
05 1Blank
01 4Active
02 4Inactive
03 1Blank
01 2Withdrawn by Holder
02 7Blank
01 9Blank
01 1WC-0107
02 8Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38998
Submission : 2023-10-06
Status : Active
Type : II
NDC Package Code : 71554-029
Start Marketing Date : 2023-10-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-06
Pay. Date : 2014-12-18
DMF Number : 5223
Submission : 1983-12-16
Status : Active
Type : II
NDC Package Code : 48087-0016
Start Marketing Date : 2010-03-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-10-27
Pay. Date : 2017-10-16
DMF Number : 4376
Submission : 1981-11-12
Status : Active
Type : II
NDC Package Code : 12828-0022
Start Marketing Date : 1986-05-01
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 : 23160
Submission : 2009-10-05
Status : Active
Type : II
Certificate Number : R0-CEP 2010-003 - Rev 03
Issue Date : 2014-09-30
Type : Chemical
Substance Number : 954
Status : Withdrawn by Holder
NDC Package Code : 65015-746
Start Marketing Date : 2015-01-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : 6162
Submission : 1986-01-13
Status : Inactive
Type : II
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Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5507
Submission : 1984-07-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3193
Submission : 1978-04-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25364
Submission : 2011-10-03
Status : Inactive
Type : II
Certificate Number : CEP 2010-282 - Rev 02
Issue Date : 2023-10-19
Type : Chemical
Substance Number : 954
Status : Withdrawn by Holder
Date of Issue : 2022-06-08
Valid Till : 2025-06-25
Written Confirmation Number : WC-0107
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