Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062365
Company: FRESENIUS KABI USA

Products on ANDA 062365

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLORAMPHENICOL SODIUM SUCCINATE	CHLORAMPHENICOL SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062365

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/25/1982	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
08/01/2016	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
11/10/2014	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
08/01/2016	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
12/05/2002	SUPPL-12	Manufacturing (CMC)-Facility		Label is not available on this site.
07/15/2002	SUPPL-11	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
04/08/1993	SUPPL-9	Labeling		Label is not available on this site.
12/15/1992	SUPPL-8	Labeling		Label is not available on this site.
09/10/1992	SUPPL-7	Labeling		Label is not available on this site.
11/23/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.