Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080983
Company: FOSUN PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SONAZINE CHLORPROMAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE;ORAL Discontinued None No No
SONAZINE CHLORPROMAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE;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
03/01/1976 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
02/23/2017 SUPPL-60 Labeling-Package Insert

Label is not available on this site.

08/12/2015 SUPPL-59 Labeling-Package Insert

Label is not available on this site.

01/24/1994 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

06/04/1992 SUPPL-53 Labeling

Label is not available on this site.

02/16/1990 SUPPL-48 Labeling

Label is not available on this site.

05/19/1988 SUPPL-45 Labeling

Label is not available on this site.

05/29/1986 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

02/08/1985 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

09/18/1984 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

06/07/1983 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

07/12/1983 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

05/18/1983 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

12/03/1982 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

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