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Last Updated: May 18, 2025

Regulatory Exclusivity: MISCELLANEOUS

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Drugs with Miscellaneous Regulatory Exclusivity

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019		DISCN	Yes	No	⤷ Try for Free	REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017		RX	Yes	No	⤷ Try for Free	REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-001	Feb 5, 2001	AB	RX	Yes	Yes	⤷ Try for Free	INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-002	Feb 5, 2001	AB	RX	Yes	No	⤷ Try for Free	INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-003	Feb 5, 2001	AB	RX	Yes	No	⤷ Try for Free	INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-004	Feb 5, 2001	AB	RX	Yes	No	⤷ Try for Free	INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
Viiv Hlthcare	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887-001	Jan 21, 2021		RX	Yes	Yes	⤷ Try for Free	REVISION TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY 207966 ATLAS-2M
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

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