Drugs@FDA: FDA-Approved Drugs
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACEPHEN | ACETAMINOPHEN | 120MG | SUPPOSITORY;RECTAL | Discontinued | None | No | No |
| ACEPHEN | ACETAMINOPHEN | 650MG | SUPPOSITORY;RECTAL | Discontinued | None | No | No |
| ACEPHEN | ACETAMINOPHEN | 325MG | SUPPOSITORY;RECTAL | 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 |
|---|---|---|---|---|---|---|---|
| 02/09/1978 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 12/02/2014 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/2014 | SUPPL-66 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018060Orig1s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018060Orig1s066ltr.pdf | |
| 11/01/2011 | SUPPL-65 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018060s065ltr.pdf |
| 04/01/2010 | SUPPL-64 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/28/2010 | SUPPL-63 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018060s063ltr.pdf |
| 02/15/2002 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/1999 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1996 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1997 | SUPPL-55 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18-060S055.pdf |
| 08/26/1987 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 10/20/1987 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 01/22/1985 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/17/1986 | SUPPL-50 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/11/1983 | SUPPL-49 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/22/1981 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 12/18/1980 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1980 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/25/1980 | SUPPL-44 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/19/1980 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 08/12/1980 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 02/21/1980 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 02/13/1980 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 02/13/1980 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 02/13/1980 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 02/20/1980 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/11/1979 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 11/06/1979 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/05/1979 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 11/05/1979 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/22/1979 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 09/12/1979 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/06/1979 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/24/1979 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/27/1979 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/14/1979 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/13/1979 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 03/06/1980 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/17/1979 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1979 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1978 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 08/31/1978 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 10/06/1978 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 10/06/1978 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 10/06/1978 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 10/06/1978 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 10/05/1978 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/05/1978 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/05/1978 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/05/1978 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/06/1978 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/05/1978 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/06/1978 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/05/1978 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/06/1978 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 10/06/1978 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 05/03/1978 | 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 |
|---|---|---|---|---|---|
| 03/25/2014 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018060Orig1s066lbl.pdf |