01 1Adenine
02 1Alprostadil
03 1Amantadine Hydrochloride
04 1Arginine Vasopressin
05 1Azacitidine
06 1Azithromycin
07 1Bendamustine Hydrochloride
08 1Bromazepam
09 1Calcitonin
10 1Calcium Polystyrene Sulfonate
11 1Carboprost Tromethamine
12 1Cholestyramine
13 1Decitabine
14 1Degarelix Acetate
15 1Desmopressin Acetate
16 1Eltrombopag
17 1Etelcalcetide
18 1Ezetimibe
19 1Ganirelix
20 1Glatiramer Acetate
21 1Icatibant Acetate
22 1Lansoprazole
23 1Leuprolide Acetate
24 1Levofloxacin
25 1Linaclotide
26 1Liraglutide
27 1Methacrylic Acid
28 1Moxifloxacin Hydrochloride
29 1Octreotide Acetate
30 1Paroxetine Hydrochloride
31 1Pemetrexed Disodium
32 1Plecanatide
33 1Pregabalin
34 1Risedronate Sodium
35 1Rosiglitazone Maleate
36 2Rosuvastatin Calcium
37 1Sodium Polystyrene Sulfonate
38 1Sulbactam Sodium
39 1Temozolomide
40 1Teriparatide
41 1Tolterodine Tartrate
42 1Treprostinil Diolamine
43 3Blank
01 22Active
02 11Inactive
03 13Blank
01 2Valid
02 1Withdrawn by Holder
03 43Blank
01 1230MF10118
02 1301MF10031
03 1306MF10062
04 1306MF10145
05 1307MF10019
06 41Blank
01 4WC-0352
02 4WC-0443
03 38Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Click Us!
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 : 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 : Reviewed
Rev. Date : 2015-08-24
Pay. Date : 2015-06-17
DMF Number : 29448
Submission : 2015-06-20
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
