Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088790
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TYLOX | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 500MG;5MG | CAPSULE;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 12/12/1984 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/30/2001 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/31/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/31/2002 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 01/24/2001 | SUPPL-12 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 04/03/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/06/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/30/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |