Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040118
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE 325MG;200MG;16MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/16/1996 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
10/16/2019 SUPPL-19 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/20/2018 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-17 REMS - PROPOSAL - D-N-A

Label is not available on this site.

08/29/2017 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

07/30/2013 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

07/30/2013 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

06/21/2011 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

08/13/2008 SUPPL-11 Labeling

Label is not available on this site.

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

Label is not available on this site.

02/01/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/10/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/10/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/10/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE

TABLET;ORAL; 325MG;200MG;16MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE 325MG;200MG;16MG TABLET;ORAL Prescription No AB 040860 INGENUS PHARMS NJ
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE 325MG;200MG;16MG TABLET;ORAL Prescription No AB 040118 SANDOZ

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