Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040116
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARISOPRODOL AND ASPIRIN ASPIRIN; CARISOPRODOL 325MG;200MG TABLET;ORAL Prescription AB 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
04/25/1996 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
01/01/2001 SUPPL-100

Label is not available on this site.

07/30/2013 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

06/20/2011 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

02/02/2000 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

12/14/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/31/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/31/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/31/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CARISOPRODOL AND ASPIRIN

TABLET;ORAL; 325MG;200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARISOPRODOL AND ASPIRIN ASPIRIN; CARISOPRODOL 325MG;200MG TABLET;ORAL Prescription No AB 089594 HERITAGE PHARMS INC
CARISOPRODOL AND ASPIRIN ASPIRIN; CARISOPRODOL 325MG;200MG TABLET;ORAL Prescription No AB 040832 NOVAST LABS
CARISOPRODOL AND ASPIRIN ASPIRIN; CARISOPRODOL 325MG;200MG TABLET;ORAL Prescription No AB 040116 SANDOZ

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