Drugs@FDA: FDA-Approved Drugs
Company: SANOFI AVENTIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TALACEN | ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE | 650MG;EQ 25MG BASE | 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 |
---|---|---|---|---|---|---|---|
09/23/1982 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/22/2011 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018458s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018458s016ltr.pdf | |
03/10/2011 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018458s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018458s014ltr.pdf | |
08/07/2008 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018458s013ltr.pdf |
07/10/2003 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18458slr012ltr.pdf |
10/31/2000 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
03/30/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/02/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/10/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
05/22/1987 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
03/27/1987 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
10/25/1985 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
05/07/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
06/26/1984 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
01/24/1984 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/22/2011 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018458s016lbl.pdf | |
03/10/2011 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018458s014lbl.pdf |