Norditropin, Norditropin Nordiflex, Norditropin Flexpro

Treats growth failure due to inadequate secretion of endogenous growth hormone (GH)…. BLA 21148, held by Novo Nordisk Inc. Somatropin.

As of Nov 13, 2026, BLA 21148 (Norditropin, Norditropin Nordiflex, Norditropin Flexpro), held by Novo Nordisk Inc, was first approved by FDA on Jun 20, 2000, with 32 approved supplements and 0 published complete response letters.

First approved: Jun 20, 2000
Review: Standard
Supplements approved: 32
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

NORDITROPIN is a recombinant human growth hormone indicated for:

Pediatric: Treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with Noonan syndrome, short stature associated with Turner syndrome, short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years, Idiopathic Short Stature (ISS), and growth failure due to Prader-Willi Syndrome
Adult: Replacement of endogenous GH in adults with growth hormone deficiency 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below

Date	Submission	Status	Documents
Feb 23, 2018	Supplement 38Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 23, 2018	Supplement 37Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 31, 2008	Supplement 23Efficacy (new indication or use)	Approved	Letter Label
Sep 20, 2007	Supplement 17Efficacy (new indication or use)	Approved	Letter Label
May 31, 2007	Supplement 16Efficacy (new indication or use)	Approved	Letter Label
Nov 1, 2004	Supplement 7Efficacy (new indication or use)	Approved	Letter
Jun 20, 2000	Original applicationNew dosage form · Standard review	Approved	Review Other Letter Label

Products

11 strengths and forms

Product	Active ingredient	Marketing
Norditropin5MG/1.5ML · injectable;injection	Somatropin	Discontinued
Norditropin10MG/1.5ML · injectable;injection	Somatropin	Discontinued
Norditropin15MG/1.5ML · injectable;injection	Somatropin	Discontinued
Norditropin Nordiflex5MG/1.5ML · injectable;injection	Somatropin	Discontinued
Norditropin Nordiflex10MG/1.5ML · injectable;injection	Somatropin	Discontinued
Norditropin Nordiflex15MG/1.5ML · injectable;injection	Somatropin	Discontinued
Norditropin Nordiflex30MG/3ML · injectable;injection	Somatropin	Discontinued
Norditropin Flexpro5MG/1.5ML · injectable;injection	Somatropin	Rx
Norditropin Flexpro10MG/1.5ML · injectable;injection	Somatropin	Rx
Norditropin Flexpro15MG/1.5ML · injectable;injection	Somatropin	Rx
Norditropin Flexpro30MG/3ML · injectable;injection	Somatropin	Rx

All 33 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 9, 2025	Supplement 62Labeling · Standard review	Approved	Letter Label
Jan 31, 2025	Supplement 58Labeling · Standard review	Approved	Letter Label
Jan 31, 2025	Supplement 56Labeling · Standard review	Approved	Letter Label
Mar 9, 2020	Supplement 53Labeling · Standard review	Approved	Letter Label
Feb 23, 2018	Supplement 38Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 23, 2018	Supplement 37Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 29, 2017	Supplement 49Labeling · Standard review	Approved	Letter Label
Jan 12, 2017	Supplement 47Manufacturing · Standard review	Approved	None posted
Dec 13, 2016	Supplement 48Labeling · Standard review	Approved	Letter Label
Jun 23, 2016	Supplement 46Manufacturing · Standard review	Approved	None posted
Jan 13, 2016	Supplement 45Manufacturing · Standard review	Approved	None posted
Jul 7, 2015	Supplement 44Labeling · Standard review	Approved	Letter Label
Jun 12, 2015	Supplement 43Labeling · Standard review	Approved	Letter
Jun 12, 2015	Supplement 28Manufacturing · Standard review	Approved	Label
Jan 23, 2015	Supplement 42Labeling · Standard review	Approved	Letter Label
Sep 25, 2014	Supplement 41Labeling · Standard review	Approved	Letter Label
Oct 14, 2013	Supplement 39Labeling · Standard review	Approved	Letter Label
May 15, 2013	Supplement 40Manufacturing · Standard review	Approved	None posted
May 25, 2011	Supplement 35Labeling	Approved	Letter Label
Mar 1, 2010	Supplement 27Manufacturing	Approved	Label
Mar 10, 2009	Supplement 25Manufacturing · Standard review	Approved	Letter Label
Oct 31, 2008	Supplement 23Efficacy (new indication or use)	Approved	Letter Label
Sep 20, 2007	Supplement 17Efficacy (new indication or use)	Approved	Letter Label
Sep 14, 2007	Supplement 18Manufacturing	Approved	Letter Label
May 31, 2007	Supplement 16Efficacy (new indication or use)	Approved	Letter Label
Feb 13, 2007	Supplement 15Labeling · Standard review	Approved	Letter Label
Sep 1, 2006	Supplement 13Labeling · Standard review	Approved	Letter Label
Apr 25, 2005	Supplement 4Manufacturing · Standard review	Approved	Letter
Nov 1, 2004	Supplement 7Efficacy (new indication or use)	Approved	Letter
Oct 1, 2004	Supplement 6Manufacturing · Standard review	Approved	Letter
Aug 16, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 30, 2001	Supplement 1Manufacturing · Standard review	Approved	Letter
Jun 20, 2000	Original applicationNew dosage form · Standard review	Approved	Review Other Letter Label

Identifiers

Application: BLA 21148
Drugs@FDA: Overview at FDA
Company: Novo Nordisk

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters

Norditropin, Norditropin Nordiflex, Norditropin Flexpro