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01 1Carteolol
02 1Chloroprocaine HCl
03 1Clenbuterol Hydrochloride
04 1Dexmedetomidine Hydrochloride
05 1Gliclazide
06 1Glimepiride
07 1Indapamide
08 1Isoproterenol Hydrochloride
09 1Lurasidone Hydrochloride
10 1Midodrine
11 1Norepinephrine Bitartrate
12 1Paracetamol
13 1Procaterol
14 1Ropivacaine Hydrochloride
15 1Stanozolol
16 1Tenoxicam
17 1Terfenadine
18 1Trimebutine Maleate
19 1Tulobuterol
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01 7Active
02 12Blank
01 1Expired
02 8Valid
03 2Withdrawn by Holder
04 8Blank
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01 1217MF10582
02 1218MF10871
03 1218MF10948
04 1221MF10193
05 1222MF10141
06 14Blank
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01 19Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-07-26
Pay. Date : 2017-05-31
DMF Number : 31569
Submission : 2017-05-15
Status : Active
Type : II
Certificate Number : CEP 2022-088 - Rev 00
Issue Date : 2024-05-15
Type : Chemical
Substance Number : 1332
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-09-04
Pay. Date : 2019-07-11
DMF Number : 34008
Submission : 2019-07-31
Status : Active
Type : II
Certificate Number : R0-CEP 2020-089 - Rev 00
Issue Date : 2021-06-08
Type : Chemical
Substance Number : 285
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-02-19
Pay. Date : 2020-12-10
DMF Number : 35401
Submission : 2020-12-21
Status : Active
Type : II
Certificate Number : R1-CEP 2007-342 - Rev 03
Issue Date : 2021-07-15
Type : Chemical
Substance Number : 2335
Status : Valid
NDC Package Code : 66583-0610
Start Marketing Date : 1998-05-01
End Marketing Date : 2025-12-31
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 : 21750
Submission : 2008-06-27
Status : Active
Type : II
Registration Number : 218MF10871
Registrant's Address : Strada Statale dei Giovi, 131-20037 Paderno Dugnano (MI) - Italy
Initial Date of Registration : 2006-11-06
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-06-28
Pay. Date : 2021-03-11
DMF Number : 35698
Submission : 2021-04-21
Status : Active
Type : II
NDC Package Code : 66583-0810
Start Marketing Date : 2021-04-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF,