01 1Cambrex Corporation
02 1Coating Place
03 1Cyalume Specialty Products
04 1Divis Laboratories
05 1Lonza Inc & Lonza America Inc
06 1Rubicon Research
07 1Solara Active Pharma Sciences
08 1Tsujimoto Chemical
01 2COATED DEXTROMETHORPHAN POLISTIREX
02 1DEXTROMETHORPHAN BASE
03 1DEXTROMETHORPHAN BASE USP
04 1DEXTROMETHORPHAN PHENOLPHTHALINATE
05 2DEXTROMETHORPHAN POLISTIREX
06 1DEXTROMETHORPHAN TANNATE
01 3India
02 1Japan
03 4U.S.A
01 4Active
02 4Inactive
01 1Complete
02 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22329
Submission : 2008-12-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18151
Submission : 2005-02-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23478
Submission : 2010-01-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-01-21
Pay. Date : 2019-07-29
DMF Number : 22469
Submission : 2009-01-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10264
Submission : 1993-05-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27347
Submission : 2013-09-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29216
Submission : 2015-03-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6561
Submission : 1986-08-07
Status : Inactive
Type : II
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