01 12-Phenoxyethanol
02 3Adenosine
03 1Adenosine 5'-Monophosphate
04 1Azelastine Hydrochloride
05 1Benzalkonium Chloride
06 1Broxuridine
07 1Ephedrine
08 1Fluocytosine
09 1Fluorouracil
10 2Glutathione
11 1Levocarnitine
12 1M-Cresol
13 1Phenol
14 1Thymidine
15 1Uridine
16 1Uridine Triphosphate
17 1Blank
01 2Active
02 12Inactive
03 6Blank
01 1Valid
02 19Blank
01 20Blank
01 20Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2016-213 - Rev 02
Issue Date : 2024-01-19
Type : Chemical
Substance Number : 781
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-08
Pay. Date : 2013-05-30
DMF Number : 7728
Submission : 1988-10-25
Status : Active
Type : II
NDC Package Code : 12562-3021
Start Marketing Date : 1996-01-01
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 : 16150
Submission : 2002-09-24
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 : 3412
Submission : 1978-12-20
Status : Inactive
Type : II
NDC Package Code : 12562-3021
Start Marketing Date : 1996-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT