Drugs@FDA: FDA-Approved Drugs
Company: MEDA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SOMA COMPOUND | ASPIRIN; CARISOPRODOL | 325MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
09/12/1960 | 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 |
---|---|---|---|---|---|
01/31/2013 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012365s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012365s039,012366s033ltr.pdf | |
11/17/2009 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012365s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/012365s038ltr.pdf | |
03/02/2000 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/01/2009 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012365s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/012365s035ltr.pdf | |
10/25/1993 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/30/1986 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
01/10/1986 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
07/11/1983 | SUPPL-29 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
04/19/1983 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/05/1983 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/05/1983 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/11/1983 | SUPPL-24 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
10/29/1981 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/15/1980 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
12/12/1974 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
07/19/1974 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
12/12/1974 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/31/2013 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012365s039lbl.pdf | |
11/17/2009 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012365s038lbl.pdf | |
04/01/2009 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012365s035lbl.pdf |