Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018495
Company: BAXTER HLTHCARE

Products on NDA 018495

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	33MG/100ML;30MG/100ML;860MG/100ML	SOLUTION;IRRIGATION	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018495

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/19/1982	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/11/2015	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
09/30/2014	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
09/28/2011	SUPPL-21	Labeling-Container/Carton Labels		Label is not available on this site.
09/14/1993	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
09/30/1994	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
01/22/1991	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/26/1991	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
11/14/1991	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
07/26/1989	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
10/30/1986	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
06/26/1985	SUPPL-7	Labeling		Label is not available on this site.
02/28/1984	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
01/24/1985	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/07/1982	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for NDA 018495

RINGER'S IN PLASTIC CONTAINER

SOLUTION;IRRIGATION; 33MG/100ML;30MG/100ML;860MG/100ML
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	33MG/100ML;30MG/100ML;860MG/100ML	SOLUTION;IRRIGATION	Prescription	No	AT	018156	B BRAUN
RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	33MG/100ML;30MG/100ML;860MG/100ML	SOLUTION;IRRIGATION	Prescription	No	AT	018495	BAXTER HLTHCARE
RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	33MG/100ML;30MG/100ML;860MG/100ML	SOLUTION;IRRIGATION	Prescription	No	AT	017635	ICU MEDICAL INC