Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 019107
Company: GENENTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROTROPIN SOMATREM 5MG/VIAL INJECTABLE;INJECTION Discontinued None No No
PROTROPIN SOMATREM 10MG/VIAL INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/17/1985 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019107Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/17/2001 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

05/02/2001 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

02/12/2001 SUPPL-48 Labeling

Label is not available on this site.

05/21/1999 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1999 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

10/07/1998 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1998 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1995 SUPPL-43 Labeling

Label is not available on this site.

05/17/1995 SUPPL-42 Labeling

Label is not available on this site.

09/22/1995 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/1995 SUPPL-40 Labeling

Label is not available on this site.

08/03/1994 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

07/21/1994 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

04/07/1994 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

04/07/1994 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

03/09/1994 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

03/31/1993 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/31/1993 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/28/1992 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1992 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1992 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/08/1992 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/1991 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

11/02/1990 SUPPL-24 Labeling

Label is not available on this site.

11/26/1990 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/25/1990 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/15/1990 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1990 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1989 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1989 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/1989 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/01/1989 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/23/1989 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

12/02/1988 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/26/1988 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/14/1988 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/1988 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/1988 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/18/1988 SUPPL-6 Efficacy-New Route Of Administration

Label is not available on this site.

11/28/1988 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/1989 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1986 SUPPL-3 Labeling

Label is not available on this site.

09/16/1986 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English