Veranova: A CDMO that manages complexity with confidence.
01 2Veranova
02 1Alkem Laboratories
03 1Apotex Pharmachem
04 1Cambrex Corporation
05 1Curia
06 1SIGMA TAU
07 1Tris Pharma Inc
01 1CATABATE, SODIUM OXYBATE, GAMMA-HYDROXYBUTYRIC ACID, SODIUM SALT
02 1GAMMA-HYDROXYBUTYRATE
03 1OXYBATE EXTENDED-RELEASE POWDER FOR ORAL SUSPENSION (OXYBATE ER POS)
04 4SODIUM OXYBATE
05 1SODIUM OXYBATE AQUEOUS CONCENTRATE
01 1Canada
02 1India
03 6U.S.A
01 6Active
02 2Inactive
01 5Complete
02 3Blank
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2012-12-19
DMF Number : 24049
Submission : 2010-08-02
Status : Active
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2022-04-25
Pay. Date : 2022-02-28
DMF Number : 36577
Submission : 2022-02-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-10-06
Pay. Date : 2022-08-17
DMF Number : 28289
Submission : 2014-06-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7249
Submission : 1987-12-11
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-31
Pay. Date : 2022-05-17
DMF Number : 35870
Submission : 2022-04-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-28
Pay. Date : 2013-12-06
DMF Number : 27599
Submission : 2013-09-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3274
Submission : 1978-07-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33094
Submission : 2018-09-11
Status : Active
Type : II
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