Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202679
Company: HOSPIRA

Products on ANDA 202679

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM BICARBONATE	SODIUM BICARBONATE	5MEQ/10ML (0.5MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202679

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/07/2017	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/14/2021	SUPPL-10	Labeling-Container/Carton Labels		Label is not available on this site.
08/29/2017	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 202679

SODIUM BICARBONATE

SOLUTION;INTRAVENOUS; 5MEQ/10ML (0.5MEQ/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM BICARBONATE	SODIUM BICARBONATE	5MEQ/10ML (0.5MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	220788	ASPIRO
SODIUM BICARBONATE	SODIUM BICARBONATE	5MEQ/10ML (0.5MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	211091	EXELA PHARMA
SODIUM BICARBONATE	SODIUM BICARBONATE	5MEQ/10ML (0.5MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	202679	HOSPIRA