01 1Aripiprazole
02 1Baclofen
03 1Benzocaine
04 1Bronopol
05 1Butamben
06 1Celecoxib
07 1Deferasirox
08 1Diltiazem
09 1Divalproex Sodium
10 1Enalapril Maleate
11 1Entacapone
12 1Ethamsylate
13 1Fenofibrate
14 1Fluvoxamine
15 1Hydroxyzine Pamoate
16 1Meloxicam
17 1Metaxalone
18 1Mirtazapine
19 2Moxifloxacin
20 1Olanzapine
21 1Piroxicam
22 1Piroxicam-Beta-Cyclodextrin
23 1Quetiapine Hemifumarate
24 1Sodium Valproate
25 1Tenoxicam
26 1Ziprasidone Hydrochloride
27 1Zonisamide
01 2Active
02 2Inactive
03 24Blank
01 3Expired
02 25Blank
01 28Blank
01 3WC-0453
02 25Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37567
Submission : 2022-11-02
Status : Active
Type : II
Certificate Number : R0-CEP 2016-068 - Rev 00
Issue Date : 2018-01-22
Type : Chemical
Substance Number : 2373
Status : Expired
Date of Issue : 2019-09-11
Valid Till : 2022-09-11
Written Confirmation Number : WC-0453
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31899
Submission : 2017-05-10
Status : Inactive
Type : II
Certificate Number : R0-CEP 2016-081 - Rev 00
Issue Date : 2017-06-21
Type : Chemical
Substance Number : 11
Status : Expired
Date of Issue : 2019-09-11
Valid Till : 2022-09-11
Written Confirmation Number : WC-0453
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31901
Submission : 2017-05-10
Status : Inactive
Type : II
Certificate Number : R0-CEP 2016-067 - Rev 00
Issue Date : 2017-05-05
Type : Chemical
Substance Number : 944
Status : Expired
Date of Issue : 2019-09-11
Valid Till : 2022-09-11
Written Confirmation Number : WC-0453
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-09-04
Pay. Date : 2024-08-13
DMF Number : 36954
Submission : 2022-03-31
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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