Nutropin

BLA 19676, held by Genentech. SOMATROPIN [rDNA origin].

As of Nov 13, 2026, BLA 19676 (Nutropin), held by Genentech, was first approved by FDA on Mar 9, 1994, with 24 approved supplements and 0 published complete response letters.

First approved: Mar 9, 1994
Review: Standard
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Feb 23, 2006	Supplement 26Efficacy (new indication or use)	Approved	Letter Label
Jun 28, 2005	Supplement 20Efficacy (new indication or use)	Approved	Letter Label Letter Label
Apr 13, 2000	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Dec 1, 1999	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Review
Dec 15, 1997	Supplement 9Efficacy (new indication or use) · Standard review	Approved	None posted
Mar 9, 1994	Original applicationNew indication · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
NutropinN/A · injectable; injection	SOMATROPIN [rDNA origin]	Rx

All 25 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 13, 2016	Supplement 44Labeling · Standard review	Approved	Letter Label Other
Apr 10, 2012	Supplement 42Labeling	Approved	Letter Label
Feb 15, 2007	Supplement 30Labeling · Standard review	Approved	Letter Label
Feb 23, 2006	Supplement 26Efficacy (new indication or use)	Approved	Letter Label
Jun 28, 2005	Supplement 21Labeling · Standard review	Approved	Letter Label Letter Label
Jun 28, 2005	Supplement 20Efficacy (new indication or use)	Approved	Letter Label Letter Label
Sep 17, 2001	Supplement 18Manufacturing · Standard review	Approved	None posted
May 2, 2001	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 13, 2000	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Dec 1, 1999	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Review
Nov 24, 1999	Supplement 15Labeling · Standard review	Approved	None posted
Nov 3, 1999	Supplement 14Manufacturing · Standard review	Approved	None posted
Sep 25, 1998	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 25, 1998	Supplement 11Manufacturing · Standard review	Approved	None posted
Dec 15, 1997	Supplement 9Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 12, 1997	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 7, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 1, 1996	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 22, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 25, 1995	Supplement 5Labeling · Standard review	Approved	None posted
Aug 21, 1995	Supplement 7Labeling · Standard review	Approved	None posted
Feb 3, 1995	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 3, 1994	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 21, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 9, 1994	Original applicationNew indication · Standard review	Approved	None posted

Identifiers

Application: BLA 19676
Drugs@FDA: Overview at FDA
Company: Genentech

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