01 1Bromfenac
02 1Bromfenac Sodium
03 1Capecitabine
04 1Citicoline Sodium
05 2Cytarabine
06 1Dihydralazine Sulfate
07 1Disopyramide
08 1Favipiravir
09 1Glycerophosphorylethanolamine
10 4Glycerylphosphorylcholine
11 1Hydralazine Hydrochloride
12 1Hydroxyurea
13 1Lithium Carbonate
14 1Mianserin Hydrochloride
15 7Oxcarbazepine
16 2Pirenzepine
17 5Sucralfate
18 1Sucrose Octasulfate
19 1Sulfapyridine
20 1Sulfathiazole Sodium
21 1Tolmetin
01 13Active
02 23Blank
01 4Valid
02 32Blank
01 36Blank
01 36Blank
01 120120316-168-I-18-01
02 120120316-168-I-18-01(2)
03 120120316-168-I-18-01(3)
04 120150506-168-I-448-13
05 32Blank
01 155512-0002
02 155512-0003
03 155512-0004
04 155512-0006
05 155512-0007
06 155512-0008
07 155512-0009
08 155512-0010
09 155512-0013
10 155512-0015
11 155512-0016
12 155512-0017
13 155512-0018
14 155512-0019
15 155512-0020
16 155512-0021
17 155512-0022
18 155512-0023
19 155512-0025
20 155512-0026
21 16Blank
01 36Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-12-18
Pay. Date : 2013-01-15
DMF Number : 25267
Submission : 2011-09-07
Status : Active
Type : II
Certificate Number : R1-CEP 2000-048 - Rev 04
Issue Date : 2020-10-16
Type : Chemical
Substance Number : 760
Status : Valid
NDC Package Code : 55512-0026
Start Marketing Date : 2019-12-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-13
Pay. Date : 2019-02-08
DMF Number : 12754
Submission : 1997-11-14
Status : Active
Type : II
Certificate Number : R1-CEP 2003-120 - Rev 03
Issue Date : 2020-09-18
Type : Chemical
Substance Number : 1616
Status : Valid
NDC Package Code : 55512-0003
Start Marketing Date : 2009-09-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-31
Pay. Date : 2013-07-18
DMF Number : 23704
Submission : 2010-04-12
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25266
Submission : 2011-09-07
Status : Active
Type : II
NDC Package Code : 55512-0015
Start Marketing Date : 2011-04-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2023-289 - Rev 00
Issue Date : 2024-02-06
Type : Chemical
Substance Number : 760
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 14204
Submission : 1999-06-11
Status : Active
Type : II
NDC Package Code : 55512-0004
Start Marketing Date : 2009-09-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Review : N/A
Rev. Date :
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DMF Number : 35933
Submission : 2021-05-22
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-27
Pay. Date : 2014-04-25
DMF Number : 22169
Submission : 2008-10-31
Status : Active
Type : II
NDC Package Code : 55512-0010
Start Marketing Date : 2009-11-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-08
Pay. Date : 2013-03-25
DMF Number : 23175
Submission : 2009-10-07
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2022-250 - Rev 00
Issue Date : 2024-11-28
Type : Chemical
Substance Number : 846
Status : Valid
