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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 1Calcium Polystyrene Sulfonate
13 1Carboprost Tromethamine
14 1Cholestyramine
15 1Cloprostenol Sodium
16 1Decitabine
17 1Degarelix Acetate
18 1Desmopressin Acetate
19 1Dinoprost Tromethamine
20 1Eltrombopag
21 1Etelcalcetide
22 4Ezetimibe
23 1Ganirelix
24 1Glatiramer Acetate
25 1Icatibant Acetate
26 1Lansoprazole
27 1Leuprolide Acetate
28 1Levofloxacin
29 1Linaclotide
30 1Liraglutide
31 1Methacrylic Acid
32 1Moxifloxacin Hydrochloride
33 1Octreotide Acetate
34 1Paroxetine Hydrochloride
35 1Pemetrexed Disodium
36 1Plecanatide
37 1Pregabalin
38 1Risedronate Sodium
39 1Rivaroxaban
40 1Rosiglitazone Maleate
41 6Rosuvastatin Calcium
42 1Sacubitril-Valsartan
43 1Sodium Polystyrene Sulfonate
44 1Sulbactam Sodium
45 1Temozolomide
46 1Teriparatide
47 1Ticagrelor
48 1Tofacitinib Citrate
49 1Tolterodine Tartrate
50 1Treprostinil Diolamine
51 3Blank
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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 4WC-0352
02 4WC-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
14 48Blank
01 16117
02 16204
03 59Blank
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 : 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
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
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-27
Pay. Date : 2014-07-01
DMF Number : 27953
Submission : 2014-03-18
Status : Active
Type : II
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
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36373
Submission : 2021-10-14
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-08
Pay. Date : 2013-01-18
DMF Number : 26708
Submission : 2012-12-11
Status : Active
Type : II