Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020002
Company: B BRAUN
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 INJECTABLE;INJECTION Prescription AP 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
04/17/1992 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
06/16/2004 SUPPL-10 Labeling

Label is not available on this site.

07/01/2002 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/15/2002 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/07/2000 SUPPL-6 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/21/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/21/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/10/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

RINGER'S IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 33MG/100ML;30MG/100ML;860MG/100ML
TE Code = AP

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 INJECTABLE;INJECTION Prescription No AP 020002 B BRAUN
RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 33MG/100ML;30MG/100ML;860MG/100ML INJECTABLE;INJECTION Prescription No AP 016693 BAXTER HLTHCARE
RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 33MG/100ML;30MG/100ML;860MG/100ML INJECTABLE;INJECTION Prescription No AP 018251 ICU MEDICAL INC

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