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01 1Adenine
02 1Agomelatine
03 1Alprostadil
04 1Amantadine Hydrochloride
05 1Ampicillin Sodium
06 1Arginine Vasopressin
07 1Azacitidine
08 1Azithromycin
09 1Baloxavir Marboxil
10 1Bendamustine Hydrochloride
11 1Bromazepam
12 1Calcitonin
13 1Carboprost Tromethamine
14 1Cloprostenol Sodium
15 1Decitabine
16 1Degarelix Acetate
17 1Desmopressin Acetate
18 1Dinoprost Tromethamine
19 1Dinoprostone
20 1Doxycycline
21 1Eltrombopag
22 1Etelcalcetide
23 5Ezetimibe
24 1Finerenone
25 1Ganirelix
26 1Glatiramer Acetate
27 1Icatibant Acetate
28 1Lansoprazole
29 3Leuprolide Acetate
30 1Levofloxacin
31 1Linaclotide
32 1Liraglutide
33 1Moxifloxacin Hydrochloride
34 2Octreotide Acetate
35 1Paroxetine Hydrochloride
36 1Pemetrexed Disodium
37 1Plecanatide
38 1Pregabalin
39 1Risedronate Sodium
40 1Rosiglitazone Maleate
41 8Rosuvastatin Calcium
42 1Sacubitril-Valsartan
43 1Sugammadex Sodium
44 1Sulbactam Sodium
45 1Temozolomide
46 1Teriparatide
47 1Teriparatide Acetate
48 2Ticagrelor
49 1Tofacitinib Citrate
50 1Tolterodine Tartrate
51 1Treprostinil Diolamine
52 1Treprostinil Sodium
53 1Upadacitinib
54 4Blank
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01 24Active
02 11Inactive
03 37Blank
01 3Valid
02 1Withdrawn by Holder
03 68Blank
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01 1230MF10118
02 1301MF10031
03 1306MF10062
04 1306MF10145
05 1307MF10019
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01 13WC-0443
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01 120210331-209-J-914
02 120210331-209-J-914(1)
03 120210331-209-J-914(2)
04 120210331-209-J-914(3)
05 120210331-209-J-914(4)
06 120210331-209-J-914(A)
07 120210331-209-J-914(B)
08 120210331-209-J-914(C)
09 120250624-101-F-102-06
10 120251202-211-J-2077
11 1Su207-52-ND
12 1Su207-76-ND
13 1Su331-28-ND
14 1Su382-7-ND
15 1Su522-8-ND
16 1Su522-8-ND(1)
17 1Su522-8-ND(A)
18 1Su522-8-ND(B)
19 1Su6199-5-ND
20 1Su69-22-ND
21 1Su69-27-ND
22 1Su946-7-ND
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01 169218-0300
02 169218-0400
03 169218-0700
04 169218-0800
05 169218-1000
06 169218-1001
07 169870-088
08 169870-093
09 169870-108
10 184344-001
11 184344-002
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01 16117
02 16204
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-03-30
Pay. Date : 2016-02-17
DMF Number : 30233
Submission : 2016-02-19
Status : Active
Type : II
Certificate Number : R1-CEP 2016-125 - Rev 01
Issue Date : 2023-03-31
Type : Chemical
Substance Number : 712
Status : Valid
Date of Issue : 2025-10-01
Valid Till : 2028-06-10
Written Confirmation Number : WC-0443
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DMF Review : Reviewed
Rev. Date : 2015-08-24
Pay. Date : 2015-06-17
DMF Number : 29448
Submission : 2015-06-20
Status : Active
Type : II
Certificate Number : CEP 2023-017 - Rev 00
Issue Date : 2025-03-28
Type : Chemical
Substance Number : 2414
Status : Valid
Date of Issue : 2025-10-01
Valid Till : 2028-06-10
Written Confirmation Number : WC-0443
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DMF Review : Reviewed
Rev. Date : 2018-09-11
Pay. Date : 2018-08-27
DMF Number : 33119
Submission : 2018-08-27
Status : Active
Type : II
Date of Issue : 2025-10-01
Valid Till : 2028-06-10
Written Confirmation Number : WC-0443
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DMF Review : Reviewed
Rev. Date : 2021-04-22
Pay. Date : 2021-03-30
DMF Number : 35791
Submission : 2021-03-30
Status : Active
Type : II
Date of Issue : 2025-10-01
Valid Till : 2028-06-10
Written Confirmation Number : WC-0443
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DMF Review : Reviewed
Rev. Date : 2020-09-08
Pay. Date : 2020-08-07
DMF Number : 35078
Submission : 2020-08-07
Status : Active
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Date of Issue : 2025-10-01
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Rev. Date : 2021-01-11
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DMF Number : 35386
Submission : 2020-11-12
Status : Active
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Date of Issue : 2025-10-01
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Written Confirmation Number : WC-0443
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DMF Review : Reviewed
Rev. Date : 2021-08-30
Pay. Date : 2021-07-13
DMF Number : 36108
Submission : 2021-07-14
Status : Active
Type : II
Date of Issue : 2025-10-01
Valid Till : 2028-06-10
Written Confirmation Number : WC-0443
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DMF Review : Reviewed
Rev. Date : 2017-02-15
Pay. Date : 2016-11-29
DMF Number : 31170
Submission : 2016-11-30
Status : Active
Type : II
Date of Issue : 2025-10-01
Valid Till : 2028-06-10
Written Confirmation Number : WC-0443
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DMF Review : Reviewed
Rev. Date : 2015-12-04
Pay. Date : 2015-09-18
DMF Number : 29708
Submission : 2015-09-22
Status : Active
Type : II
Date of Issue : 2025-10-01
Valid Till : 2028-06-10
Written Confirmation Number : WC-0443
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DMF Review : N/A
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DMF Number : 34239
Submission : 2020-04-21
Status : Active
Type : II
