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 2Desmopressin Acetate
16 1Etelcalcetide
17 1Ezetimibe
18 1Ganirelix
19 1Glatiramer Acetate
20 1Icatibant Acetate
21 1Lansoprazole
22 1Leuprolide Acetate
23 1Levofloxacin
24 1Linaclotide
25 1Liraglutide
26 1Methacrylic Acid
27 1Moxifloxacin Hydrochloride
28 1Octreotide Acetate
29 1Paroxetine Hydrochloride
30 1Pemetrexed Disodium
31 1Plecanatide
32 1Pregabalin
33 1Risedronate Sodium
34 1Rosiglitazone Maleate
35 1Rosuvastatin Calcium
36 1Sodium Polystyrene Sulfonate
37 1Sulbactam Sodium
38 1Temozolomide
39 1Teriparatide
40 1Tolterodine Tartrate
41 1Treprostinil Diolamine
42 3Blank
01 22Active
02 11Inactive
03 12Blank
01 2Valid
02 1Withdrawn by Holder
03 42Blank
01 1230MF10118
02 1301MF10031
03 1306MF10062
04 42Blank
01 4WC-0352
02 2WC-0443
03 3WC-0443-A1-2
04 36Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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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 : 2019-06-11
Valid Till : 2022-06-11
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 : 2022-06-10
Valid Till : 2019-07-22
Written Confirmation Number : WC-0443-A1-2
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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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 : 2022-06-10
Valid Till : 2019-07-22
Written Confirmation Number : WC-0443-A1-2
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 : 2019-06-11
Valid Till : 2022-06-11
Written Confirmation Number : WC-0443
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
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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
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