Drugs@FDA: FDA-Approved Drugs
Company: SANOFI AVENTIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TALWIN NX | NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE | EQ 0.5MG BASE;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
12/16/1982 | ORIG-1 | Approval | Type 4 - New Combination | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/24/2011 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018733s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018733s015ltr.pdf | |
09/01/2008 | SUPPL-14 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018733s014lbl.pdf | |
02/26/2003 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18733slr012ltr.pdf |
02/29/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/12/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
02/02/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/09/1985 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
01/12/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
04/05/1983 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/05/1983 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/05/1983 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/05/1983 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/05/1983 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/05/1983 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/24/2011 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018733s015lbl.pdf | |
09/01/2008 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018733s014lbl.pdf |