Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040910
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYCODONE AND ASPIRIN | ASPIRIN; OXYCODONE HYDROCHLORIDE | 325MG;4.8355MG | TABLET;ORAL | Prescription | AA | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/16/2020 | ORIG-1 | Approval |
Label is not available on this site. |
OXYCODONE AND ASPIRIN
TABLET;ORAL; 325MG;4.8355MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXYCODONE AND ASPIRIN | ASPIRIN; OXYCODONE HYDROCHLORIDE | 325MG;4.8355MG | TABLET;ORAL | Prescription | No | AA | 040910 | EPIC PHARMA LLC |
PERCODAN | ASPIRIN; OXYCODONE HYDROCHLORIDE | 325MG;4.8355MG | TABLET;ORAL | Prescription | Yes | AA | 007337 | ENDO OPERATIONS |