← FDA DRUG APPROVALS

FDA BLA · BLA021148

NORDITROPIN

somatropin

Sponsor: NOVO NORDISK INC

APPLICATION
BLA021148
TYPE
BLA
ORIGINAL APPROVAL
2000-06-20
LATEST ACTION
2025-07-09
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

NORDITROPIN FLEXPROPrescription
SOMATROPIN 5MG/1.5ML · INJECTABLE · INJECTION
NORDITROPIN NORDIFLEXDiscontinued
SOMATROPIN 15MG/1.5ML · INJECTABLE · INJECTION
NORDITROPIN NORDIFLEXDiscontinued
SOMATROPIN 5MG/1.5ML · INJECTABLE · INJECTION
NORDITROPIN FLEXPROPrescription
SOMATROPIN 15MG/1.5ML · INJECTABLE · INJECTION
NORDITROPINDiscontinued
SOMATROPIN 10MG/1.5ML · INJECTABLE · INJECTION
NORDITROPIN FLEXPROPrescription
SOMATROPIN 10MG/1.5ML · INJECTABLE · INJECTION
NORDITROPIN NORDIFLEXDiscontinued
SOMATROPIN 30MG/3ML · INJECTABLE · INJECTION
NORDITROPIN NORDIFLEXDiscontinued
SOMATROPIN 10MG/1.5ML · INJECTABLE · INJECTION
NORDITROPIN FLEXPROPrescription
SOMATROPIN 30MG/3ML · INJECTABLE · INJECTION
NORDITROPINDiscontinued
SOMATROPIN 15MG/1.5ML · INJECTABLE · INJECTION
NORDITROPINDiscontinued
SOMATROPIN 5MG/1.5ML · INJECTABLE · INJECTION

Approval history

2025-07-09Labeling · Supplement 62 · standard — Letter ↗AP
2025-01-31Labeling · Supplement 58 · standard — Letter ↗AP
2025-01-31Labeling · Supplement 56 · standard — Letter ↗AP
2020-03-09Labeling · Supplement 53 · standard — Letter ↗AP
2018-02-23Efficacy · Supplement 37 · standard — Letter ↗AP
2018-02-23Efficacy · Supplement 38 · standard — Letter ↗AP
2017-08-29Labeling · Supplement 49 · standard — Letter ↗AP
2017-01-12Manufacturing (CMC) · Supplement 47 · standardAP
2016-12-13Labeling · Supplement 48 · standard — Letter ↗AP
2016-06-23Manufacturing (CMC) · Supplement 46 · standardAP
2016-01-13Manufacturing (CMC) · Supplement 45 · standardAP
2015-07-07Labeling · Supplement 44 · standard — Letter ↗AP
2015-06-12Labeling · Supplement 43 · standard — Letter ↗AP
2015-06-12Manufacturing (CMC) · Supplement 28 · standard — Label ↗AP
2015-01-23Labeling · Supplement 42 · standard — Label ↗AP
2014-09-25Labeling · Supplement 41 · standard — Letter ↗AP
2013-10-14Labeling · Supplement 39 · standard — Label ↗AP
2013-05-15Manufacturing (CMC) · Supplement 40 · standardAP
2011-05-25Labeling · Supplement 35 · unknown — Letter ↗AP
2010-03-01Manufacturing (CMC) · Supplement 27 — Label ↗AP
2009-03-10Manufacturing (CMC) · Supplement 25 · standard — Letter ↗AP
2008-10-31Efficacy · Supplement 23 · unknown — Letter ↗AP
2007-09-20Efficacy · Supplement 17 · unknown — Label ↗AP
2007-09-14Manufacturing (CMC) · Supplement 18 — Letter ↗AP
2007-05-31Efficacy · Supplement 16 · unknown — Letter ↗AP
2007-02-13Labeling · Supplement 15 · standard — Letter ↗AP
2006-09-01Labeling · Supplement 13 · standard — Letter ↗AP
2005-04-25Manufacturing (CMC) · Supplement 4 · standard — Letter ↗AP
2004-11-01Efficacy · Supplement 7 · unknown — Letter ↗AP
2004-10-01Manufacturing (CMC) · Supplement 6 · standard — Letter ↗AP
2001-08-16Manufacturing (CMC) · Supplement 2 · standardAP
2001-03-30Manufacturing (CMC) · Supplement 1 · standard — Letter ↗AP
2000-06-20Type 3 - New Dosage Form · Original · standard — Other ↗AP
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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