AMI Lifesciences is Driven by Chemistry. Powered by People.
01 1Ami Lifesciences Private Limited
02 1Catalent Pharma Solutions
03 1Formosa Laboratories
04 1Grace
05 1KINGLAND CHEMICALS CO LTD
06 1Novartis Pharmaceuticals Corporation
07 1Siegfried AG
01 3BENZONATATE
02 2BENZONATATE USP
03 1TESSALON 100 MG AND 200 MG SOFTGEL CAPSULES AND BENZONATATE 100 MG AND 200 MG SOFTGEL CAPSULES
04 1TESSALON DRUG SUBSTANCE, (BENZONATATE, USP)
01 1China
02 1India
03 2Switzerland
04 1Taiwan
05 2U.S.A
01 4Active
02 3Inactive
01 3Complete
02 4Blank
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39002
Submission : 2023-12-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12327
Submission : 1997-01-21
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-03
Pay. Date : 2013-05-03
DMF Number : 21703
Submission : 2008-06-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-06
Pay. Date : 2013-05-23
DMF Number : 5196
Submission : 1983-12-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 24194
Submission : 2010-09-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 12421
Submission : 1997-03-14
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-31
Pay. Date : 2014-10-23
DMF Number : 7843
Submission : 1988-12-19
Status : Active
Type : II
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