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01 1Adenine
02 1Alprostadil
03 1Amantadine Hydrochloride
04 1Ampicillin Sodium
05 1Apixaban
06 1Arginine Vasopressin
07 1Azacitidine
08 1Azithromycin
09 1Bendamustine Hydrochloride
10 1Bromazepam
11 1Calcitonin
12 1Carboprost Tromethamine
13 1Cloprostenol Sodium
14 1Decitabine
15 1Degarelix Acetate
16 1Desmopressin Acetate
17 1Dinoprost Tromethamine
18 1Dinoprostone
19 1Doxycycline
20 1Eltrombopag
21 1Etelcalcetide
22 5Ezetimibe
23 1Finerenone
24 1Ganirelix
25 1Glatiramer Acetate
26 1Icatibant Acetate
27 1Lansoprazole
28 3Leuprolide Acetate
29 1Levofloxacin
30 1Linaclotide
31 1Liraglutide
32 1Moxifloxacin Hydrochloride
33 2Octreotide Acetate
34 1Paroxetine Hydrochloride
35 1Pemetrexed Disodium
36 1Plecanatide
37 1Pregabalin
38 1Risedronate Sodium
39 1Rivaroxaban
40 1Rosiglitazone Maleate
41 7Rosuvastatin 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
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02 11Inactive
03 35Blank
01 3Valid
02 1Withdrawn by Holder
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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)
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05 120210331-209-J-914(4)
06 120210331-209-J-914(A)
07 120210331-209-J-914(B)
08 120250624-101-F-102-06
09 1Su207-52-ND
10 1Su331-28-ND
11 1Su382-7-ND
12 1Su522-8-ND
13 1Su522-8-ND(1)
14 1Su522-8-ND(A)
15 1Su522-8-ND(B)
16 1Su6199-5-ND
17 1Su69-22-ND
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01 169218-0100
02 169218-0300
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08 169218-0900
09 169218-1000
10 169218-1001
11 169870-088
12 169870-093
13 169870-108
14 184344-001
15 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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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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Rev. Date : 2018-09-11
Pay. Date : 2018-08-27
DMF Number : 33119
Submission : 2018-08-27
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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Rev. Date : 2021-04-22
Pay. Date : 2021-03-30
DMF Number : 35791
Submission : 2021-03-30
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 : 2020-09-08
Pay. Date : 2020-08-07
DMF Number : 35078
Submission : 2020-08-07
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Rev. Date : 2021-08-30
Pay. Date : 2021-07-13
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
Status : Active
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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 Review : N/A
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DMF Number : 34239
Submission : 2020-04-21
Status : Active
Type : II
