Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080983
Company: FOSUN PHARMA

Products on ANDA 080983

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080983

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
02/05/2020	SUPPL-61	Labeling-Package Insert		Label is not available on this site.
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.