Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012365
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SOMA COMPOUND ASPIRIN; CARISOPRODOL 325MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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
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

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