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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | RYDAPT | midostaurin | CAPSULE;ORAL | 207997-001 | Apr 28, 2017 | RX | Yes | Yes | Start Trial | Start Trial | TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) WHO ARE FLT3 MUTATION-POSITIVE, IN COMBINATION WITH STANDARD CYTARABINE AND DAUNORUBICIN INDUCTION AND CYTARABINE CONSOLIDATION CHEMOTHERAPY | ||||
| Assertio | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | BX | RX | Yes | Yes | Start Trial | Start Trial | Y | TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA | ||
| Assertio | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | BX | RX | Yes | Yes | Start Trial | Start Trial | Y | TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA | ||
| Assertio | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | BX | RX | Yes | Yes | Start Trial | Start Trial | Y | TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA | ||
| Assertio | GRALISE | gabapentin | TABLET;ORAL | 022544-002 | Jan 28, 2011 | BX | RX | Yes | Yes | Start Trial | Start 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 |
