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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 4Ezetimibe
22 1Ganirelix
23 1Glatiramer Acetate
24 1Icatibant Acetate
25 1Lansoprazole
26 3Leuprolide Acetate
27 1Levofloxacin
28 1Linaclotide
29 1Liraglutide
30 1Moxifloxacin Hydrochloride
31 2Octreotide Acetate
32 1Paroxetine Hydrochloride
33 1Pemetrexed Disodium
34 1Plecanatide
35 1Pregabalin
36 1Risedronate Sodium
37 1Rivaroxaban
38 1Rosiglitazone Maleate
39 6Rosuvastatin Calcium
40 1Sulbactam Sodium
41 1Temozolomide
42 1Teriparatide
43 1Teriparatide Acetate
44 1Ticagrelor
45 1Tofacitinib Citrate
46 1Tolterodine Tartrate
47 1Treprostinil Diolamine
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01 22Active
02 11Inactive
03 30Blank
01 3Valid
02 1Withdrawn by Holder
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01 1230MF10118
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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(A)
06 120210331-209-J-914(B)
07 120250624-101-F-102-06
08 169-22-ND
09 1No. 522-8-ND(1)
10 1No. 522-8-ND(A)
11 1No. 522-8-ND(B)
12 1Number 207-52-ND
13 1Su382-7-ND
14 1Su522-8-ND
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01 169218-0100
02 169218-0300
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04 169218-0500
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06 169218-0700
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09 169870-088
10 169870-093
11 169870-108
12 184344-001
13 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 : 2022-09-07
Valid Till : 2025-06-10
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 : 2022-09-07
Valid Till : 2025-06-10
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 : 2022-09-07
Valid Till : 2025-06-10
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 : 2022-09-07
Valid Till : 2025-06-10
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 : 2022-09-07
Valid Till : 2025-06-10
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
Type : II
Date of Issue : 2022-09-07
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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 : 2022-09-07
Valid Till : 2025-06-10
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 : 2022-09-07
Valid Till : 2025-06-10
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 : 2022-09-07
Valid Till : 2025-06-10
Written Confirmation Number : WC-0443
Address of the Firm :
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GDUFA
DMF Review : N/A
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Pay. Date :
DMF Number : 34239
Submission : 2020-04-21
Status : Active
Type : II