Regulatory Exclusivity: EXCLUSIVITY WAIVED BY SPONSOR
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Drugs with Exclusivity Waived By Sponsor Regulatory Exclusivity
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Exclusivity Expiration | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Uihc Pet Imaging | GALLIUM GA 68 EDOTREOTIDE | gallium ga-68 edotreotide | SOLUTION;INTRAVENOUS | 210828-001 | Aug 21, 2019 | RX | Yes | Yes | ⤷ Sign Up | EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY | |
| Feinstein | FLUORODOPA F18 | fluorodopa f-18 | SOLUTION;INTRAVENOUS | 200655-001 | Oct 10, 2019 | RX | Yes | Yes | ⤷ Sign Up | EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY | |
| Univ Ca Los Angeles | GALLIUM GA 68 GOZETOTIDE | gallium ga-68 gozetotide | SOLUTION;INTRAVENOUS | 212642-001 | Dec 1, 2020 | RX | Yes | Yes | ⤷ Sign Up | EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY | |
| Univ Of Ca San Fran | GALLIUM GA 68 GOZETOTIDE | gallium ga-68 gozetotide | SOLUTION;INTRAVENOUS | 212643-001 | Dec 1, 2020 | RX | Yes | Yes | ⤷ Sign Up | EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY | |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Exclusivity Expiration | >Patented / Exclusive Use |
