Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089346
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARISOPRODOL CARISOPRODOL 350MG 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
10/17/1991 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/30/2014 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

07/26/2013 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

03/09/2010 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

03/20/2009 SUPPL-33 Labeling

Label is not available on this site.

01/25/2007 SUPPL-30 Labeling

Label is not available on this site.

09/27/2002 SUPPL-18 Labeling

Label is not available on this site.

09/27/2002 SUPPL-17 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/27/2002 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/06/2001 SUPPL-14 Labeling

Label is not available on this site.

11/06/2001 SUPPL-13 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

11/06/2001 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/08/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2000 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

07/06/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/15/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/05/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/05/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/05/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/22/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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