Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202495
Company: HOSPIRA

Products on ANDA 202495

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM BICARBONATE	SODIUM BICARBONATE	10MEQ/10ML (1MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202495

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/06/2017	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-9	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 202495

SODIUM BICARBONATE

SOLUTION;INTRAVENOUS; 10MEQ/10ML (1MEQ/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM BICARBONATE	SODIUM BICARBONATE	10MEQ/10ML (1MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	220788	ASPIRO
SODIUM BICARBONATE	SODIUM BICARBONATE	10MEQ/10ML (1MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	211091	EXELA PHARMA
SODIUM BICARBONATE	SODIUM BICARBONATE	10MEQ/10ML (1MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	202495	HOSPIRA