Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018186
Company: B BRAUN

Products on NDA 018186

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER	SODIUM LACTATE	1.87GM/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018186

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/1979	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
03/24/1993	SUPPL-16	Labeling		Label is not available on this site.
09/11/1990	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
06/24/1985	SUPPL-13	Labeling		Label is not available on this site.
04/03/1985	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
06/28/1985	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
02/18/1986	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
10/26/1981	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/24/1981	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
01/24/1983	SUPPL-7	Labeling		Label is not available on this site.
09/25/1980	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/24/1980	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/06/1980	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/12/1980	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/09/1979	SUPPL-2	Labeling		Label is not available on this site.
10/16/1979	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.