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01 12-Phosphonomethyl-Pentanedioic Acid
02 1Aconiazide
03 1Amphotericin B
04 1Cobicistat
05 1Didanosine
06 1Dobutamine Hydrochloride
07 1Elvitegravir
08 1Emtricitabine
09 1Lurtotecan
10 1Tenofovir
11 1Triacetyluridine
12 1Zalcitabine
13 8Blank
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01 3Active
02 15Inactive
03 2Blank
01 20Blank
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01 1227MF10232
02 1229MF10061
03 18Blank
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01 20Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9564
Submission : 1992-03-06
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 : 25188
Submission : 2011-10-24
Status : Active
Type : II
NDC Package Code : 54014-9350
Start Marketing Date : 2012-08-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25187
Submission : 2011-10-21
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 229MF10061
Registrant's Address : 1021 Hayter Road Edmonton, Alberta T6S 1A1, Canada
Initial Date of Registration : 2017-03-07
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 227MF10232
Registrant's Address : 1021 Hayter Road Edmonton, Alberta T6S 1A1, Canada
Initial Date of Registration : 2015-09-24
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 : 12688
Submission : 1997-10-07
Status : Inactive
Type : II