Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 083040
Company: FOSUN PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SONAZINE CHLORPROMAZINE HYDROCHLORIDE 10MG/5ML SYRUP;ORAL 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
03/04/1976 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/05/2020 SUPPL-44 Labeling-Package Insert

Label is not available on this site.

02/23/2017 SUPPL-43 Labeling-Package Insert

Label is not available on this site.

05/01/2012 SUPPL-42 Labeling-Package Insert

Label is not available on this site.

01/24/1994 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

06/04/1992 SUPPL-40 Labeling

Label is not available on this site.

06/14/1990 SUPPL-39 Labeling

Label is not available on this site.

09/12/1989 SUPPL-35 Labeling

Label is not available on this site.

08/04/1988 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

08/04/1988 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

08/04/1988 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

05/19/1988 SUPPL-31 Labeling

Label is not available on this site.

05/29/1986 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/11/1985 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/06/1983 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/08/1983 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/24/1982 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/19/1982 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/19/1982 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/19/1982 SUPPL-16 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