← FDA DRUG APPROVALS

FDA BLA · BLA019676

NUTROPIN

Sponsor: GENENTECH

APPLICATION
BLA019676
TYPE
BLA
ORIGINAL APPROVAL
1994-03-09
LATEST ACTION
2016-12-13
ROUTE
Injection
DOSAGE FORM
Injectable
MARKETING STATUS
Prescription

Products

NUTROPINPrescription
SOMATROPIN [rDNA origin] N/A · Injectable · Injection

Approval history

2016-12-13Labeling · Supplement 44 · standard — Label ↗AP
2012-04-10Labeling · Supplement 42 · unknown — Letter ↗AP
2007-02-15Labeling · Supplement 30 · standard — Letter ↗AP
2006-02-23Efficacy · Supplement 26 · unknown — Letter ↗AP
2005-06-28Labeling · Supplement 21 · standard — Letter ↗AP
2005-06-28Efficacy · Supplement 20 · unknown — Label ↗AP
2001-09-17Manufacturing (CMC) · Supplement 18 · standardAP
2001-05-02Manufacturing (CMC) · Supplement 17 · standardAP
2000-04-13Efficacy · Supplement 16 · standard — Review ↗AP
1999-12-01Efficacy · Supplement 13 · standard — Review ↗AP
1999-11-24Labeling · Supplement 15 · standardAP
1999-11-03Manufacturing (CMC) · Supplement 14 · standardAP
1998-09-25Manufacturing (CMC) · Supplement 11 · standardAP
1998-09-25Manufacturing (CMC) · Supplement 12 · standardAP
1997-12-15Efficacy · Supplement 9 · standardAP
1997-09-12Manufacturing (CMC) · Supplement 10 · standardAP
1996-08-07Manufacturing (CMC) · Supplement 8 · standardAP
1996-02-01Manufacturing (CMC) · Supplement 4 · standardAP
1995-09-22Manufacturing (CMC) · Supplement 6 · standardAP
1995-08-25Labeling · Supplement 5 · standardAP
1995-08-21Labeling · Supplement 7 · standardAP
1995-02-03Manufacturing (CMC) · Supplement 3 · standardAP
1994-08-03Manufacturing (CMC) · Supplement 2 · standardAP
1994-07-21Manufacturing (CMC) · Supplement 1 · standardAP
1994-03-09Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval · Original · standardAP
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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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