Mechanism of Action: Topoisomerase Inhibitors
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Drugs with Mechanism of Action: Topoisomerase Inhibitors
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer Inc | CAMPTOSAR | irinotecan hydrochloride | INJECTABLE;INJECTION | 020571-001 | Jun 14, 1996 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pfizer Inc | CAMPTOSAR | irinotecan hydrochloride | INJECTABLE;INJECTION | 020571-002 | Jun 14, 1996 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pfizer Inc | CAMPTOSAR | irinotecan hydrochloride | INJECTABLE;INJECTION | 020571-003 | Aug 5, 2010 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hisun Pharm Hangzhou | DAUNORUBICIN HYDROCHLORIDE | daunorubicin hydrochloride | INJECTABLE;INJECTION | 208759-001 | Apr 12, 2019 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | DAUNORUBICIN HYDROCHLORIDE | daunorubicin hydrochloride | INJECTABLE;INJECTION | 050731-001 | Jan 30, 1998 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Baxter Hlthcare Corp | DOXIL (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 050718-001 | Nov 17, 1995 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Baxter Hlthcare Corp | DOXIL (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 050718-002 | Jun 13, 2000 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
