01 1Bio-Technology General Israel Ltd.
02 1KREITMAN ROBERT J MD
03 1Qijian Bio Pharmaceutical Co Ltd
04 1Sandoz B2B
05 1Blank
01 1INTERLEUKIN-6 PSEUDOMONAS EXOTOXIN FUSION PROTEIN (HUMAN, RECOMBINANT, E. COLI)
02 2RECOMBINANT HUMAN GROWTH HORMONE
03 1SOMATROPIN (HUMAN GROWTH HORMONE) SANDOZ
04 1SOMATROPIN (RECOMBINANT HUMAN GROWTH HORMONE) API
01 1China
02 1Israel
03 1Switzerland
04 1U.S.A
05 1Blank
01 3Active
02 2Inactive
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20147
Submission : 2006-12-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18630
Submission : 1994-04-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33745
Submission : 2019-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17719
Submission : 2004-10-05
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7037
Submission : 1987-06-22
Status : Inactive
Type : II
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