01 1Chemische Fabrik Berg
02 1Aarti Drugs
03 1COSMA S.p.A
04 1Calyx Chemicals & Pharmaceuticals Limited
05 1Chemi SpA
06 3DMFs Not Supported
07 1Emcure Pharmaceuticals
08 1Fleming Laboratories
09 1Glochem Industries
10 1Ipca Laboratories
11 1Siegfried AG
12 1Srikem Laboratories Pvt. Ltd
13 1Symed Labs
14 1Teikoku Seiyaku Co., Ltd.
15 2UCB Pharma S.A
01 4HYDROXYZINE HCL
02 1HYDROXYZINE HCL N.F. XIV
03 1HYDROXYZINE HCL.USP. XX 093082
04 1HYDROXYZINE HYDROCHIORIDE
05 6HYDROXYZINE HYDROCHLORIDE
06 1HYDROXYZINE HYDROCHLORIDE COMPACTED
07 4HYDROXYZINE HYDROCHLORIDE USP
01 2Belgium
02 1Germany
03 8India
04 2Italy
05 1Japan
06 1Switzerland
07 3Blank
01 9Active
02 9Inactive
01 5Complete
02 13Blank
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-12
Pay. Date : 2023-12-01
DMF Number : 35249
Submission : 2023-12-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24002
Submission : 2010-07-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-15
Pay. Date : 2014-01-28
DMF Number : 4435
Submission : 1982-01-29
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2807
Submission : 1976-11-22
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39539
Submission : 2024-03-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38273
Submission : 2023-08-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37118
Submission : 2022-11-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-17
Pay. Date : 2013-08-08
DMF Number : 23283
Submission : 2010-04-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-03
Pay. Date : 2014-07-11
DMF Number : 28376
Submission : 2014-06-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-11-18
Pay. Date : 2016-10-24
DMF Number : 19596
Submission : 2006-07-12
Status : Active
Type : II
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