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 |