Last Updated: August 10, 2026

Mechanism of Action: Carbamoyl Phosphate Synthetase 1 Activators

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Drugs with Mechanism of Action: Carbamoyl Phosphate Synthetase 1 Activators

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novitium Pharma	CARGLUMIC ACID	carglumic acid	TABLET, FOR SUSPENSION;ORAL	213729-001	Oct 13, 2021	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Navinta Llc	CARGLUMIC ACID	carglumic acid	TABLET, FOR SUSPENSION;ORAL	213395-001	Jun 22, 2022	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Recordati Rare	CARBAGLU	carglumic acid	TABLET, FOR SUSPENSION;ORAL	022562-001	Mar 18, 2010	AB	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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