01 1Bio-Technology General Israel Ltd.
02 1KREITMAN ROBERT J MD
03 1Merck Group
04 1Qijian Bio Pharmaceutical Co Ltd
05 1Sandoz B2B
06 1Blank
01 1ASELLACRIN (SOMATROPIN)
02 1INTERLEUKIN-6 PSEUDOMONAS EXOTOXIN FUSION PROTEIN (HUMAN, RECOMBINANT, E. COLI)
03 2RECOMBINANT HUMAN GROWTH HORMONE
04 1SOMATROPIN (HUMAN GROWTH HORMONE) SANDOZ
05 1SOMATROPIN (RECOMBINANT HUMAN GROWTH HORMONE) API
01 1China
02 1Germany
03 1Israel
04 1Switzerland
05 1U.S.A
06 1Blank
01 3Active
02 3Inactive
01 6Blank
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 : 4478
Submission : 1982-03-10
Status : Inactive
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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