Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040860
Company: INGENUS PHARMS NJ
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 None 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
01/07/2010 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
05/07/2021 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

03/04/2021 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

10/07/2019 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-3 REMS - PROPOSAL - D-N-A

Label is not available on this site.

08/29/2017 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

08/29/2017 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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