Polyene Antifungal Drug Class List
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Drugs in Drug Class: Polyene Antifungal
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Leadiant Biosci Inc | ABELCET | amphotericin b | INJECTABLE, LIPID COMPLEX;INJECTION | 050724-001 | Nov 20, 1995 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Astellas | AMBISOME | amphotericin b | INJECTABLE, LIPOSOMAL;INJECTION | 050740-001 | Aug 11, 1997 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Spil | AMPHOTERICIN B | amphotericin b | INJECTABLE, LIPOSOMAL;INJECTION | 212514-001 | Dec 14, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Eugia Pharma | AMPHOTERICIN B | amphotericin b | INJECTABLE, LIPOSOMAL;INJECTION | 214010-001 | Nov 17, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Xgen Pharms | AMPHOTERICIN B | amphotericin b | INJECTABLE;INJECTION | 063206-001 | Apr 29, 1992 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell Molecules | NILSTAT | nystatin | SUSPENSION;ORAL | 050299-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Upsher Smith Labs | NYSTATIN | nystatin | POWDER;TOPICAL | 065183-001 | May 3, 2005 | AT | RX | No | 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 |
