01 1BASF
02 1Bhagat Aromatics
03 1Frey + Lau GmbH
04 1Jindal Drugs
05 1Koshiro Pharmaceutical
06 1Mentha & Allied Products
07 1NAGAOKA AND CO LTD
08 2Nectar Lifesciences
09 1Neeru Menthol
10 1Norex Flavours
11 1S D Fine Chem Limited
12 2Sharp Mint Limited
13 1Silverline Chemical
14 1Swati Menthol
15 2Symrise
16 1THE SUZUKI MENTHOL CO LTD
17 1Takasago International
18 2Toyo Hakka Kogyo
19 1Blank
01 4Germany
02 12India
03 6Japan
04 1Blank
01 12Active
02 1Inactive
03 10Blank
01 4Valid
02 19Blank
01 1217MF10175
02 1217MF10179
03 1217MF10801
04 1217MF11171
05 1218MF10275
06 1218MF10705
07 17Blank
01 1WC-0005
02 1WC-0059
03 2WC-0145
04 1WC-0343
05 1WC-0437
06 17Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-08-26
Pay. Date : 2020-06-08
DMF Number : 26711
Submission : 2012-12-03
Status : Active
Type : II
Certificate Number : R1-CEP 2012-390 - Rev 01
Issue Date : 2021-06-16
Type : Chemical
Substance Number : 619
Status : Valid
NDC Package Code : 48041-0001
Start Marketing Date : 2014-07-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28691
Submission : 2014-09-29
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37683
Submission : 2022-11-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35643
Submission : 2021-02-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23408
Submission : 2009-12-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15452
Submission : 2001-05-11
Status : Active
Type : II
Registration Number : 217MF10801
Registrant's Address : Hyogo Prefecture Nishinomiya City Nishinomiyahama 4-7-18
Initial Date of Registration : 2005-11-01
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35376
Submission : 2021-01-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30689
Submission : 2016-06-23
Status : Active
Type : IV
Registration Number : 217MF11171
Registrant's Address : 5-37-1 Kamata, Ota-ku, Tokyo
Initial Date of Registration : 2005-12-12
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22154
Submission : 2008-11-03
Status : Active
Type : II
Certificate Number : R1-CEP 2004-100 - Rev 03
Issue Date : 2020-04-21
Type : Chemical
Substance Number : 619
Status : Valid
Registration Number : 218MF10705
Registrant's Address : Muehlenfeldstrasse 1 D-37 603 Holzminden Germany
Initial Date of Registration : 2006-08-11
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23027
Submission : 2009-07-29
Status : Inactive
Type : IV
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