Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012366
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CARISOPRODOL; CODEINE PHOSPHATE 325MG;200MG;16MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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

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