Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017726
Company: SERONO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ASELLACRIN 10 SOMATROPIN 10 IU/VIAL INJECTABLE;INJECTION Discontinued None No No
ASELLACRIN 2 SOMATROPIN 2 IU/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
07/30/1976 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/20/1984 SUPPL-37 Labeling

Label is not available on this site.

12/20/1984 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

12/20/1984 SUPPL-34 Labeling

Label is not available on this site.

06/22/1984 SUPPL-32 Labeling

Label is not available on this site.

06/22/1984 SUPPL-31 Labeling

Label is not available on this site.

07/18/1983 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1983 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1983 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1983 SUPPL-26 Labeling

Label is not available on this site.

07/21/1983 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/1982 SUPPL-24 Labeling

Label is not available on this site.

09/15/1982 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/29/1982 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/28/1981 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/1981 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1983 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/21/1983 SUPPL-16 Labeling

Label is not available on this site.

04/09/1981 SUPPL-15 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/28/1980 SUPPL-14 Labeling

Label is not available on this site.

11/28/1980 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/21/1980 SUPPL-12 Labeling

Label is not available on this site.

02/21/1980 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1978 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1978 SUPPL-4 Labeling

Label is not available on this site.

07/19/1978 SUPPL-3 Labeling

Label is not available on this site.

07/19/1978 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1979 SUPPL-1 Manufacturing (CMC)

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