Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019632
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;30MG/100ML;600MG/100ML;310MG/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
02/29/1988 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
06/17/2016 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

08/06/2004 SUPPL-22 Labeling

Label is not available on this site.

07/01/2002 SUPPL-21 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/15/2002 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/07/2000 SUPPL-18 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/15/2000 SUPPL-17 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/21/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/26/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/21/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/29/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/29/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/18/1990 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/22/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/13/1990 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/26/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/05/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/21/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/21/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/25/1988 SUPPL-1 Labeling

Label is not available on this site.

LACTATED RINGER'S IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription No AP 019632 B BRAUN
LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription Yes AP 016682 BAXTER HLTHCARE
LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML INJECTABLE;INJECTION Prescription No AP 017641 ICU MEDICAL INC

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