01 1Amphetamine
02 1Apomorphine Hydrochloride
03 1Buprenorphine
04 1Buprenorphine Hydrochloride
05 1Codeine Phosphate
06 1Ethylmorphine Hydrochloride
07 1Hydrocodone Bitartrate
08 1Hydromorphone Hydrochloride
09 1Lisdexamfetamine Dimesylate
10 1Pramipexole Dihydrochloride
11 1Remifentanil
12 1Risedronate Sodium
13 1Terbinafine Hydrochloride
14 1Tolfenamic Acid
01 2Active
02 12Blank
01 1Expired
02 7Valid
03 6Blank
01 14Blank
01 14Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-11-15
Pay. Date : 2021-07-14
DMF Number : 35988
Submission : 2021-07-30
Status : Active
Type : II
Certificate Number : R0-CEP 2020-339 - Rev 01
Issue Date : 2022-06-21
Type : Chemical
Substance Number : 1181
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22869
Submission : 2009-06-12
Status : Active
Type : II
Certificate Number : R1-CEP 2010-174 - Rev 01
Issue Date : 2020-04-09
Type : Chemical
Substance Number : 2416
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R0-CEP 2019-097 - Rev 00
Issue Date : 2020-02-21
Type : Chemical
Substance Number : 2752
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R0-CEP 2021-098 - Rev 00
Issue Date : 2022-11-14
Type : Chemical
Substance Number : 1180
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2010-117 - Rev 02
Issue Date : 2022-08-04
Type : Chemical
Substance Number : 2099
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2010-156 - Rev 02
Issue Date : 2019-05-15
Type : Chemical
Substance Number : 1734
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R0-CEP 2020-004 - Rev 00
Issue Date : 2021-07-16
Type : Chemical
Substance Number : 2039
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R0-CEP 2017-232 - Rev 00
Issue Date : 2019-03-13
Type : Chemical
Substance Number : 74
Status : Expired
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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