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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213395
Company: NAVINTA LLC

Products on ANDA 213395

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARGLUMIC ACID	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213395

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/22/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213395

CARGLUMIC ACID

TABLET, FOR SUSPENSION;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARBAGLU	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION;ORAL	Prescription	Yes	AB	022562	RECORDATI RARE
CARGLUMIC ACID	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	213395	NAVINTA LLC
CARGLUMIC ACID	CARGLUMIC ACID	200MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	213729	NOVITIUM PHARMA

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