01 1Amprenavir
02 1Atrasentan
03 1Benzonatate
04 1Bexarotene
05 1Calcifediol
06 2Calcitriol
07 2Cyclosporine
08 1Doxcercalciferol
09 2Dutasteride
10 1Enzalutamide
11 1Estradiol
12 1Ethosuximide
13 1Hyaluronidase
14 4Ibuprofen
15 1Icosapent Ethyl
16 1Isotretinoin
17 1Lopinavir
18 1Loratadine
19 1Lubiprostone
20 2Miconazole
21 1Miconazole Nitrate
22 2Nifedipine
23 2Nimodipine
24 1Omega-3-Acid Ethyl Esters 90
25 2Palonosetron
26 2Paricalcitol
27 2Progesterone
28 2Risperidone
29 1Ritonavir
30 1Selegiline Hydrochloride
31 1Terazosin HCl
32 4Tetrahydrocannabinol
33 1Tipranavir
34 1Tretinoin
35 1Vitamin D
36 1talarozole
37 30Blank
01 4Active
02 77Inactive
03 1Blank
01 82Blank
01 1302MF10030
02 81Blank
01 82Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 302MF10030
Registrant's Address : 1300 South Patterson Drive, Bloomington, Indiana 47403 USA
Initial Date of Registration : 2020-02-20
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22207
Submission : 2008-11-21
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 : 15914
Submission : 2002-03-27
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others