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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 1Doxycycline
19 1Eltrombopag
20 1Etelcalcetide
21 3Ezetimibe
22 1Finerenone
23 1Ganirelix
24 1Glatiramer Acetate
25 1Icatibant Acetate
26 1Lansoprazole
27 3Leuprolide Acetate
28 1Levofloxacin
29 1Linaclotide
30 1Liraglutide
31 1Moxifloxacin Hydrochloride
32 2Octreotide Acetate
33 1Paroxetine Hydrochloride
34 1Pemetrexed Disodium
35 1Plecanatide
36 1Pregabalin
37 1Risedronate Sodium
38 1Rivaroxaban
39 1Rosiglitazone Maleate
40 7Rosuvastatin Calcium
41 1Sugammadex Sodium
42 1Sulbactam Sodium
43 1Temozolomide
44 1Teriparatide
45 1Teriparatide Acetate
46 2Ticagrelor
47 1Tofacitinib Citrate
48 1Tolterodine Tartrate
49 1Treprostinil Diolamine
50 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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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
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 : 2021-01-11
Pay. Date : 2020-11-12
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