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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Healthcare | VITRAKVI | larotrectinib sulfate | SOLUTION;ORAL | 211710-001 | Nov 26, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | METHOD OF TREATING CMN, IFS, HGG, DIPGS, PTC, SOFT TISSUE SARCOMA, AND SPINDLE CELL SARCOMA SOLID TUMORS EXHIBITING AN NTRK GENE FUSION IN A PEDIATRIC PATIENT WITH AN ORAL SOLUTION | ||||
| Bayer Healthcare | VITRAKVI | larotrectinib sulfate | SOLUTION;ORAL | 211710-001 | Nov 26, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ||||
| Bayer Healthcare | VITRAKVI | larotrectinib sulfate | SOLUTION;ORAL | 211710-001 | Nov 26, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ||||
| Sun Pharm | DRIZALMA SPRINKLE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 212516-001 | Jul 19, 2019 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ||||
| Sun Pharm | DRIZALMA SPRINKLE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 212516-001 | Jul 19, 2019 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use |
