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01 1Adenine
02 1Agomelatine
03 1Alprostadil
04 1Amantadine Hydrochloride
05 1Ampicillin Sodium
06 1Apixaban
07 1Arginine Vasopressin
08 1Azacitidine
09 1Azithromycin
10 1Baloxavir Marboxil
11 1Bendamustine Hydrochloride
12 1Bromazepam
13 1Calcitonin
14 1Carboprost Tromethamine
15 1Cloprostenol Sodium
16 1Decitabine
17 1Degarelix Acetate
18 1Desmopressin Acetate
19 1Dinoprost Tromethamine
20 1Dinoprostone
21 1Doxycycline
22 1Eltrombopag
23 1Etelcalcetide
24 5Ezetimibe
25 1Finerenone
26 1Ganirelix
27 1Glatiramer Acetate
28 1Icatibant Acetate
29 1Lansoprazole
30 3Leuprolide Acetate
31 1Levofloxacin
32 1Linaclotide
33 1Liraglutide
34 1Moxifloxacin Hydrochloride
35 1Niraparib Tosylate
36 2Octreotide Acetate
37 1Paroxetine Hydrochloride
38 1Pemetrexed Disodium
39 1Plecanatide
40 1Pregabalin
41 1Risedronate Sodium
42 1Rivaroxaban
43 1Rosiglitazone Maleate
44 8Rosuvastatin Calcium
45 1Sacubitril-Valsartan
46 1Sugammadex Sodium
47 1Sulbactam Sodium
48 1Temozolomide
49 1Teriparatide
50 1Teriparatide Acetate
51 2Ticagrelor
52 1Tofacitinib Citrate
53 1Tolterodine Tartrate
54 1Treprostinil Diolamine
55 1Treprostinil Sodium
56 1Upadacitinib
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01 24Active
02 11Inactive
03 39Blank
01 3Valid
02 1Withdrawn by Holder
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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 169218-0100
02 169218-0300
03 169218-0400
04 169218-0500
05 169218-0600
06 169218-0700
07 169218-0800
08 169218-0900
09 169218-1000
10 169218-1001
11 169218-1002
12 169870-088
13 169870-093
14 169870-108
15 184344-001
16 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
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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
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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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Pay. Date : 2018-08-27
DMF Number : 33119
Submission : 2018-08-27
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Written Confirmation Number : WC-0443
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Rev. Date : 2021-04-22
Pay. Date : 2021-03-30
DMF Number : 35791
Submission : 2021-03-30
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Date of Issue : 2025-10-01
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Rev. Date : 2020-09-08
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DMF Number : 35078
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Rev. Date : 2021-08-30
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DMF Number : 36108
Submission : 2021-07-14
Status : Active
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Date of Issue : 2025-10-01
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DMF Review : Reviewed
Rev. Date : 2017-02-15
Pay. Date : 2016-11-29
DMF Number : 31170
Submission : 2016-11-30
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Date of Issue : 2025-10-01
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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
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Date of Issue : 2025-10-01
Valid Till : 2028-06-10
Written Confirmation Number : WC-0443
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DMF Number : 34239
Submission : 2020-04-21
Status : Active
Type : II
