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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018893
Company: HOSPIRA

Products on NDA 018893

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM ACETATE	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes
SODIUM ACETATE	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes
SODIUM ACETATE	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018893

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/04/1983	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
06/12/2014	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
09/02/2014	SUPPL-25	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018893s025lbl.pdf
03/03/2003	SUPPL-17	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18893scs017ltr.pdf
02/16/2001	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/31/1999	SUPPL-15	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/22/1999	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
06/15/2000	SUPPL-13	Labeling		Label is not available on this site.
05/05/1998	SUPPL-12	Labeling		Label is not available on this site.
08/29/1996	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
01/17/1997	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
11/17/1988	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
12/11/1987	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
07/24/1986	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
05/14/1985	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
10/22/1984	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
03/15/1985	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
01/17/1984	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 018893

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/02/2014	SUPPL-25	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018893s025lbl.pdf

Therapeutic Equivalents for NDA 018893

SODIUM ACETATE

SOLUTION;INTRAVENOUS; 40MEQ/20ML (2MEQ/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM ACETATE	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216920	HIKMA
SODIUM ACETATE	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	018893	HOSPIRA
SODIUM ACETATE	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214805	MILLA PHARMS

SOLUTION;INTRAVENOUS; 100MEQ/50ML (2MEQ/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM ACETATE	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	218469	AMNEAL
SODIUM ACETATE	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216920	HIKMA
SODIUM ACETATE	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	018893	HOSPIRA
SODIUM ACETATE	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214805	MILLA PHARMS
SODIUM ACETATE	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219826	SOMERSET THERAPS LLC

SOLUTION;INTRAVENOUS; 200MEQ/100ML (2MEQ/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM ACETATE	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	218469	AMNEAL
SODIUM ACETATE	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216920	HIKMA
SODIUM ACETATE	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	018893	HOSPIRA
SODIUM ACETATE	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214805	MILLA PHARMS
SODIUM ACETATE	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219826	SOMERSET THERAPS LLC

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