← FDA DRUG APPROVALS

FDA BLA · BLA020522

NUTROPIN AQ PEN

Sponsor: GENENTECH

APPLICATION
BLA020522
TYPE
BLA
ORIGINAL APPROVAL
1995-12-29
LATEST ACTION
2025-07-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

NUTROPIN AQ PENDiscontinued
SOMATROPIN 20MG/2ML (10MG/ML) · INJECTABLE · INJECTION
NUTROPIN AQ NUSPINPrescription
SOMATROPIN 20MG/2ML (10MG/ML) · INJECTABLE · INJECTION
NUTROPIN AQ PENDiscontinued
SOMATROPIN 10MG/2ML (5MG/ML) · INJECTABLE · INJECTION
NUTROPIN AQ NUSPINPrescription
SOMATROPIN 10MG/2ML (5MG/ML) · INJECTABLE · INJECTION
NUTROPIN AQ NUSPINPrescription
SOMATROPIN 5MG/2ML (2.5MG/ML) · INJECTABLE · INJECTION
NUTROPIN AQDiscontinued
SOMATROPIN 10MG/2ML (5MG/ML) · INJECTABLE · INJECTION

Approval history

2025-07-09Labeling · Supplement 68 · standard — Letter ↗AP
2016-12-13Labeling · Supplement 61 · standard — Other ↗AP
2016-11-30Manufacturing (CMC) · Supplement 60 · standardAP
2016-05-18Manufacturing (CMC) · Supplement 59 · standardAP
2016-03-17Manufacturing (CMC) · Supplement 58 · standardAP
2016-02-26Manufacturing (CMC) · Supplement 57 · standardAP
2016-01-13Manufacturing (CMC) · Supplement 56 · standardAP
2015-06-23Manufacturing (CMC) · Supplement 55 · standardAP
2015-05-26Manufacturing (CMC) · Supplement 54 · standardAP
2014-06-18Labeling · Supplement 51 · standard — Label ↗AP
2014-05-15Manufacturing (CMC) · Supplement 52 · standardAP
2013-09-17Manufacturing (CMC) · Supplement 50 · standardAP
2013-07-18Manufacturing (CMC) · Supplement 49 · standardAP
2012-04-10Labeling · Supplement 45 · unknown — Label ↗AP
2008-01-03Manufacturing (CMC) · Supplement 37 — Letter ↗AP
2008-01-03Manufacturing (CMC) · Supplement 36 — Letter ↗AP
2008-01-03Manufacturing (CMC) · Supplement 26 · standard — Letter ↗AP
2007-02-15Labeling · Supplement 33 · standard — Letter ↗AP
2005-11-18Efficacy · Supplement 27 · unknown — Letter ↗AP
2005-06-28Efficacy · Supplement 21 · unknown — Letter ↗AP
2005-06-28Labeling · Supplement 22 · standard — Letter ↗AP
2002-04-22Manufacturing (CMC) · Supplement 17 · standard — Letter ↗AP
2001-09-17Manufacturing (CMC) · Supplement 16 · standardAP
2001-09-17Manufacturing (CMC) · Supplement 14 · standardAP
2001-05-02Manufacturing (CMC) · Supplement 15 · standardAP
2000-04-13Efficacy · Supplement 13 · standard — Review ↗AP
1999-12-01Efficacy · Supplement 9 · standard — Review ↗AP
1999-11-24Labeling · Supplement 11 · standard — Review ↗AP
1999-11-03Manufacturing (CMC) · Supplement 10 · standardAP
1999-10-13Manufacturing (CMC) · Supplement 12 · standardAP
1998-10-26Manufacturing (CMC) · Supplement 6 · standardAP
1998-09-25Manufacturing (CMC) · Supplement 7 · standardAP
1998-09-25Manufacturing (CMC) · Supplement 8 · standardAP
1998-07-09Manufacturing (CMC) · Supplement 5 · standardAP
1997-12-17Efficacy · Supplement 4 · unknown — Review ↗AP
1997-09-12Manufacturing (CMC) · Supplement 3 · standardAP
1997-03-24Efficacy · Supplement 2 · standard — Review ↗AP
1996-08-07Manufacturing (CMC) · Supplement 1 · standardAP
1995-12-29Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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