Drugs@FDA: FDA Approved Drug Products

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

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

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