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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020002
Company: B BRAUN

Products on NDA 020002

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020002

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
11/03/2021	SUPPL-32	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019632s050,019634s050,020002s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019632Orig1s050, 019634Orig1s050, 020002Orig1s032ltr.pdf
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.

Labels for NDA 020002

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/03/2021	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019632s050,019634s050,020002s032lbl.pdf

Therapeutic Equivalents for NDA 020002

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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