01 13M Company
02 1Grace
03 2ORGAMOL PHARMA SOLUTIONS SA
04 2Procos
05 2R L Fine Chem
06 1Blank
01 5ORPHENADRINE CITRATE
02 1ORPHENADRINE CITRATE AND ORPHENADRINE HCL.
03 1ORPHENADRINE CITRATE USP
04 1ORPHENADRINE CITRATE/ORPHENADRINE HCL (TRANSFER TO DMF 4811 1/13/88)
05 1ORPHENADRINE HYROCHLORIDE & ORPHENADRINE CITRATE
01 2India
02 2Italy
03 2Switzerland
04 2U.S.A
05 1Blank
01 4Active
02 5Inactive
01 2Complete
02 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7108
Submission : 1987-08-11
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-16
Pay. Date : 2013-07-05
DMF Number : 5722
Submission : 1985-02-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4457
Submission : 1982-02-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4811
Submission : 1983-01-21
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-13
Pay. Date : 2014-10-31
DMF Number : 14971
Submission : 2000-07-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2942
Submission : 1977-05-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33901
Submission : 2019-05-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38456
Submission : 2023-06-05
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7837
Submission : 1988-12-20
Status : Inactive
Type : II
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