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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211091
Company: EXELA PHARMA

Products on ANDA 211091

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM BICARBONATE	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes
SODIUM BICARBONATE	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes
SODIUM BICARBONATE	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211091

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/20/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211091

SODIUM BICARBONATE

INJECTABLE;INJECTION; 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	0.5MEQ/ML	INJECTABLE;INJECTION	Prescription	No	AP	211091	EXELA PHARMA
SODIUM BICARBONATE	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE;INJECTION	Prescription	No	AP	202679	HOSPIRA
SODIUM BICARBONATE	SODIUM BICARBONATE	0.5MEQ/ML	INJECTABLE;INJECTION	Prescription	No	AP	202981	HOSPIRA

INJECTABLE;INJECTION; 0.9MEQ/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM BICARBONATE	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE;INJECTION	Prescription	No	AP	211091	EXELA PHARMA
SODIUM BICARBONATE	SODIUM BICARBONATE	0.9MEQ/ML	INJECTABLE;INJECTION	Prescription	No	AP	202494	HOSPIRA

INJECTABLE;INJECTION; 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	1MEQ/ML	INJECTABLE;INJECTION	Prescription	No	AP	211091	EXELA PHARMA
SODIUM BICARBONATE	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE;INJECTION	Prescription	No	AP	202432	HOSPIRA
SODIUM BICARBONATE	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE;INJECTION	Prescription	No	AP	202494	HOSPIRA
SODIUM BICARBONATE	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE;INJECTION	Prescription	No	AP	203449	INTL MEDICATION SYS
SODIUM BICARBONATE	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE;INJECTION	Prescription	No	AP	216042	NIVAGEN PHARMS INC
SODIUM BICARBONATE	SODIUM BICARBONATE	1MEQ/ML	INJECTABLE;INJECTION	Prescription	No	AP	216364	OMNIVIUM PHARMS

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