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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012365
Company: MEDA PHARMS

Products on NDA 012365

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SOMA COMPOUND	ASPIRIN; CARISOPRODOL	325MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012365

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.

Labels for NDA 012365

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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