01 1COSMA S.p.A
02 1Chemi SpA
03 1Napp Technologies
04 1POLI INDUSTRIA CHIMICA SPA
05 1Ramdev Chemicals Pvt Ltd
06 1Symed Labs
07 1UCB Pharma S.A
01 3HYDROXYZINE PAMOATE
02 2HYDROXYZINE PAMOATE USP
03 1HYDROXYZINE PAMOATE USP. XX
04 1MFG & CONTRL PROCEDS.--PRODUCT. OF HYDROXYZINE PAMOATE NF XIV-LODI,NJ
01 1Belgium
02 2India
03 3Italy
04 1U.S.A
01 3Active
02 4Inactive
01 3Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4629
Submission : 1982-08-11
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-28
Pay. Date : 2013-09-24
DMF Number : 4514
Submission : 1982-04-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3508
Submission : 1979-04-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2808
Submission : 1976-11-29
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-09-04
Pay. Date : 2024-08-13
DMF Number : 36954
Submission : 2022-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-07
Pay. Date : 2023-07-27
DMF Number : 38535
Submission : 2023-07-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3695
Submission : 1980-01-16
Status : Inactive
Type : II
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