01 1Baxter Healthcare Corporation
02 1Bayer AG
03 1CSL
04 1Italfarmaco S.p.A
05 8Laboratorios Farmaceuticos Rovi
06 1Luitpold Pharmaceuticals, Inc.
07 1Merck Serono
08 1Otsuka Chemical Co Ltd
09 1Teva Pharmaceutical Industries
10 1Vetter Pharma-Fertigung GmbH & Co
11 1Blank
01 5STERILE WATER FOR INJECTION
02 1STERILE WATER FOR INJECTION 10 ML PREFILLED SYRINGE
03 1STERILE WATER FOR INJECTION 2.2ML PREFILLED SYRINGE
04 1STERILE WATER FOR INJECTION FOR RECONSTITUTION
05 2STERILE WATER FOR INJECTION USP
06 1STERILE WATER FOR INJECTION USP 0.5 ML
07 1STERILE WATER FOR INJECTION USP 2.0 ML
08 1STERILE WATER FOR INJECTION USP, 2 ML VIAL
09 1STERILE WATER FOR INJECTION, 0.5-1.0 ML PREFILLED SYRINGE
10 1STERILE WATER FOR INJECTION, 1 ML PREFILLED SYRINGE
11 1STERILE WATER FOR INJECTION, 5-10 ML PREFILLED SYRINGE
12 1STERILE WATER FOR INJECTION, USP, 5.0 ML
13 1STERILE WATER FOR INJECTION,USP
01 1Australia
02 3Germany
03 1Israel
04 1Italy
05 1Japan
06 8Spain
07 2U.S.A
08 1Blank
01 8Active
02 10Inactive
01 18Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15925
Submission : 2002-04-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19257
Submission : 2006-03-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30768
Submission : 2016-07-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30419
Submission : 2016-03-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26758
Submission : 2012-12-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25234
Submission : 2011-08-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37945
Submission : 2023-01-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23992
Submission : 2010-07-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10473
Submission : 1993-09-14
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10696
Submission : 1994-01-25
Status : Inactive
Type : II
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