Mechanism of Action: Opioid Agonists
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Drugs with Mechanism of Action: Opioid Agonists
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms Ny | REPREXAIN | hydrocodone bitartrate; ibuprofen | TABLET;ORAL | 076642-003 | Oct 19, 2007 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Amneal Pharms Ny | REPREXAIN | hydrocodone bitartrate; ibuprofen | TABLET;ORAL | 076642-004 | Oct 19, 2007 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Sovereign Pharms | OBREDON | guaifenesin; hydrocodone bitartrate | SOLUTION;ORAL | 205474-001 | Nov 14, 2014 | DISCN | Yes | No | 9,549,907 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| Sovereign Pharms | OBREDON | guaifenesin; hydrocodone bitartrate | SOLUTION;ORAL | 205474-001 | Nov 14, 2014 | DISCN | Yes | No | 9,808,431 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| Sovereign Pharms | OBREDON | guaifenesin; hydrocodone bitartrate | SOLUTION;ORAL | 205474-001 | Nov 14, 2014 | DISCN | Yes | No | 10,105,324 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-005 | Aug 25, 2011 | RX | Yes | Yes | 8,114,383 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-001 | Aug 25, 2011 | RX | Yes | No | 7,994,364*PED | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
