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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 1Eltrombopag
19 1Etelcalcetide
20 4Ezetimibe
21 1Ganirelix
22 1Glatiramer Acetate
23 1Icatibant Acetate
24 1Lansoprazole
25 3Leuprolide Acetate
26 1Levofloxacin
27 1Linaclotide
28 1Liraglutide
29 1Moxifloxacin Hydrochloride
30 2Octreotide Acetate
31 1Paroxetine Hydrochloride
32 1Pemetrexed Disodium
33 1Plecanatide
34 1Pregabalin
35 1Risedronate Sodium
36 1Rivaroxaban
37 1Rosiglitazone Maleate
38 6Rosuvastatin Calcium
39 1Sacubitril-Valsartan
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 28Blank
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(A)
06 120210331-209-J-914(B)
07 1207-52-ND
08 1No. 522-8-ND(1)
09 1No. 522-8-ND(A)
10 1No. 946-7-ND
11 1Su382-7-ND
12 1Su522-8-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 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
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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
Address of the Firm :
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GDUFA
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
Valid Till : 2025-06-10
Written Confirmation Number : WC-0443
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GDUFA
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
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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 :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34239
Submission : 2020-04-21
Status : Active
Type : II