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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012366
Company: MEDA PHARMS

Products on NDA 012366

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CARISOPRODOL; CODEINE PHOSPHATE	325MG;200MG;16MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012366

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.

Labels for NDA 012366

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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