Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085375
Company: ORTHO MCNEIL PHARM
Company: ORTHO MCNEIL PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TYLOX | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE | 500MG;4.5MG;0.38MG | CAPSULE;ORAL | Discontinued | None | No | No |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/15/1984 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1983 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/1984 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |