Drugs@FDA: FDA-Approved Drugs
Company: MEDA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SOMA COMPOUND W/ CODEINE | ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE | 325MG;200MG;16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
10/05/1960 | 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 |
---|---|---|---|---|---|
05/09/2013 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012366s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012366Orig1s034ltr.pdf | |
01/31/2013 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012366s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012365s039,012366s033ltr.pdf | |
11/06/2009 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012366s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/012366s032ltr.pdf | |
10/23/2008 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/012366s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/012366s031ltr.pdf | |
03/02/2000 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
06/22/2001 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/15/1998 | SUPPL-26 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
10/22/1993 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/16/1986 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
02/23/1984 | SUPPL-19 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
07/11/1983 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
04/19/1983 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/05/1983 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/05/1983 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/23/1982 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
10/29/1981 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/16/1981 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/16/1981 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
07/19/1974 | SUPPL-6 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/09/2013 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012366s034lbl.pdf | |
01/31/2013 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012366s033lbl.pdf | |
11/06/2009 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012366s032lbl.pdf | |
10/23/2008 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/012366s031lbl.pdf |