01 1Cambrex Corporation
02 1Centaur Pharmaceuticals
03 1F.I.S. Fabbrica Italiana Sintetici
04 1R L Fine Chem
05 1Sandoz B2B
06 1Viatris
07 1Wyeth Pharmaceuticals Inc
08 1Blank
01 6TEMAZEPAM
02 2TEMAZEPAM USP
01 2India
02 1Italy
03 1Switzerland
04 3U.S.A
05 1Blank
01 4Active
02 4Inactive
01 2Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-27
Pay. Date : 2017-10-16
DMF Number : 4376
Submission : 1981-11-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25364
Submission : 2011-10-03
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-06
Pay. Date : 2014-12-18
DMF Number : 5223
Submission : 1983-12-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38998
Submission : 2023-10-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5507
Submission : 1984-07-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23160
Submission : 2009-10-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3193
Submission : 1978-04-05
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6162
Submission : 1986-01-13
Status : Inactive
Type : II
Portfolio PDF
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