01 1Avesta Pharma
02 1Clariant
03 1Clariant Chemicals China Ltd
04 1JenKem Technology Co., Ltd.
05 2Nektar Therapeutics
06 1SIGMA TAU
07 3SUNBIO INC
08 1The Dow Chemical Company
09 3Xiamen SINOPEG Biotech
01 12-arm PEG-MAL(LYS01)-40K
02 14-ARM POLYETHYLENE GLYCOL AMINE 10,000
03 14-ARM POLYETHYLENE GLYCOL SUCCINIMIDYL GLUTARATE 10,000
04 18ARM PEG SUCCINIMIDYL GLUTARATE (HEXAGLYCEROL) MW 15000
05 1CARBOWAX POLYETHYLENE GLYCOL
06 1MACROGOLS (INN)=POLYETHYLENE GLYCOLS (NF)
07 1METHOXYPOLY (ETHYLENE GLYCOL) PROPIONALDEHYDE
08 1METHOXYPOLY (ETHYLENE GLYCOL) SUCCINIMIDYL SUCCINATE 5K
09 1METHOXYPOLY (ETHYLENE GLYCOL)- PROPIONALDEHYDE, MW 20, 000
10 1METHOXYPOLY (ETHYLENE GLYCOL)- SUCCINIMIDYL CARBONATE, MW 12,000
11 1POLYETHYLENE GLYCOL
12 1POLYETHYLENE GLYCOL 3350 USP
13 1POLYETHYLENE GLYCOL 3350 USP/NF
14 1POLYETHYLENE GLYCOL DISUCCINIMIDYL PROPIONATE 3,400
01 5China
02 1India
03 3South Korea
04 1Switzerland
05 4U.S.A
01 12Active
02 2Inactive
01 3Complete
02 11Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-05
Pay. Date : 2013-09-26
DMF Number : 27419
Submission : 2013-08-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13091
Submission : 1998-07-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-10
Pay. Date : 2018-02-28
DMF Number : 32355
Submission : 2018-03-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30302
Submission : 2015-10-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27131
Submission : 2000-06-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30610
Submission : 2016-05-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30155
Submission : 2015-12-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29395
Submission : 2015-05-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-11
Pay. Date : 2012-11-16
DMF Number : 1356
Submission : 1969-03-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31041
Submission : 2016-09-25
Status : Active
Type : II
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