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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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