Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018896
Company: HOSPIRA

Products on NDA 018896

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POTASSIUM ACETATE	POTASSIUM ACETATE	2MEQ/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018896

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/20/1984	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-22	Manufacturing (CMC)		Label is not available on this site.
12/24/2002	SUPPL-12	Manufacturing (CMC)-Control	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18896scs012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/18896Orig1s012.pdf
02/16/2001	SUPPL-11	Manufacturing (CMC)-Packaging	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/18896Orig1s011.pdf
08/31/1999	SUPPL-10	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/22/1999	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
02/11/2000	SUPPL-8	Labeling		Label is not available on this site.
08/13/1998	SUPPL-7	Labeling		Label is not available on this site.
08/29/1996	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
01/17/1997	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
10/21/1988	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
12/11/1987	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
07/24/1986	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for NDA 018896

POTASSIUM ACETATE

INJECTABLE;INJECTION; 2MEQ/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
POTASSIUM ACETATE	POTASSIUM ACETATE	2MEQ/ML	INJECTABLE;INJECTION	Prescription	No	AP	212692	EXELA PHARMA
POTASSIUM ACETATE	POTASSIUM ACETATE	2MEQ/ML	INJECTABLE;INJECTION	Prescription	No	AP	217515	FRESENIUS KABI USA
POTASSIUM ACETATE	POTASSIUM ACETATE	2MEQ/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018896	HOSPIRA