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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cipla Usa | ZEMDRI | plazomicin sulfate | SOLUTION;INTRAVENOUS | 210303-001 | Jun 25, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS | |||
| Pharmacyclics Inc | IMBRUVICA | ibrutinib | SUSPENSION;ORAL | 217003-001 | Aug 24, 2022 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY | ||||
| Kowa Pharms | SEGLENTIS | celecoxib; tramadol hydrochloride | TABLET;ORAL | 213426-001 | Oct 15, 2021 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | ||||
| Novartis Pharm | TABRECTA | capmatinib hydrochloride | TABLET;ORAL | 213591-001 | May 6, 2020 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | Y | |||
| Novartis Pharm | TABRECTA | capmatinib hydrochloride | TABLET;ORAL | 213591-002 | May 6, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use |
