Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089018
Company: CENCI
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES W/ CODEINE CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 10MG/5ML;30MG/5ML;1.25MG/5ML SYRUP;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
07/23/1986 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
09/28/1992 SUPPL-3 Labeling

Label is not available on this site.

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