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01 1Amlodipine Besylate
02 1Baclofen
03 1Benzonatate
04 1Bisoctrizole
05 1Cefepime Hydrochloride
06 1Ceftriaxone
07 1Chlorhexidine Gluconate
08 1Chlorthalidone
09 1Clofazimine
10 1Clomipramine Hydrochloride
11 1Collagen
12 1Cyclosporine
13 1Dodecyl Sulfate
14 1Edotreotide
15 1Eudragit Rs
16 1Fluvastatin
17 1Glycolide - lactide copolymer
18 1Letrozole
19 1Lutetium Chloride Lu-177
20 1Lysine Hydrochloride
21 1Methylphenidate Hydrochloride
22 1NAFTIFINE HCL
23 1Naphazoline Hydrochloride
24 1Nevirapine
25 1Penicillin G Benzathine
26 1Pentetreotide
27 1Pyrilamine
28 1Pyrilamine Maleate
29 1Rifampicin
30 1Terbinafine
31 1Thurfyl Nicotinate
32 1Topotecan Hydrochloride
33 1Valsartan
34 1Zidovudine
35 20Blank
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01 9Active
02 38Inactive
03 7Blank
01 3Valid
02 1Withdrawn by Holder
03 50Blank
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01 1220MF10136
02 1220MF10223
03 1222MF10083
04 1223MF10116
05 1227MF10097
06 49Blank
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01 54Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9906
Submission : 1992-10-09
Status : Active
Type : II
Registration Number : 227MF10097
Registrant's Address : Lichtstrasse 35, CH-4056 Basel, Switzerland
Initial Date of Registration : 2015-04-09
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23902
Submission : 2010-07-02
Status : Active
Type : II
Certificate Number : CEP 2016-290 - Rev 03
Issue Date : 2024-10-16
Type : Chemical
Substance Number : 2423
Status : Valid
Registrant Name : Novartis Korea Ltd.
Registration Date : 2011-12-09
Registration Number : 20111209-135-H-172-28
Manufacturer Name : Novartis Grimsby Ltd.
Manufacturer Address : Moody Lane, Pyewipe, Grimsby_N.E. Lincolnshire/DN31 2SR/England
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2008-122 - Rev 02
Issue Date : 2023-12-14
Type : Chemical
Substance Number : 1491
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9643
Submission : 1992-04-15
Status : Active
Type : II