APPLICATION
BLA020168
TYPE
BLA
ORIGINAL APPROVAL
1993-11-17
LATEST ACTION
2016-12-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NUTROPINDiscontinued
SOMATROPIN 10MG/VIAL · INJECTABLE · INJECTION
NUTROPINDiscontinued
SOMATROPIN 5MG/VIAL · INJECTABLE · INJECTION
Approval history
2001-09-17Manufacturing (CMC) · Supplement 18 · standardAP
2001-05-02Manufacturing (CMC) · Supplement 17 · standardAP
1999-11-03Manufacturing (CMC) · Supplement 15 · standardAP
1998-09-25Manufacturing (CMC) · Supplement 13 · standardAP
1998-09-25Manufacturing (CMC) · Supplement 14 · standardAP
1997-09-12Manufacturing (CMC) · Supplement 12 · standardAP
1996-08-07Manufacturing (CMC) · Supplement 11 · standardAP
1996-04-05Manufacturing (CMC) · Supplement 8 · standardAP
1996-02-01Manufacturing (CMC) · Supplement 9 · standardAP
1995-09-22Manufacturing (CMC) · Supplement 7 · standardAP
1995-08-25Labeling · Supplement 6 · standardAP
1995-08-21Labeling · Supplement 10 · standardAP
1994-08-03Manufacturing (CMC) · Supplement 5 · standardAP
1994-07-21Manufacturing (CMC) · Supplement 4 · standardAP
1994-04-15Manufacturing (CMC) · Supplement 2 · standardAP
1994-04-15Manufacturing (CMC) · Supplement 3 · standardAP
1994-03-15Manufacturing (CMC) · Supplement 1 · standardAP
1993-11-17Type 5 - New Formulation or New Manufacturer · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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