Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088704
Company: STI PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIACIN-C CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 10MG/5ML;30MG/5ML;1.25MG/5ML SYRUP;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
03/22/1985 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
06/28/2018 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

08/29/2017 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

03/15/2017 SUPPL-36 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/15/2017 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

01/13/2017 SUPPL-34 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

07/08/2015 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

10/02/2000 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/19/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/31/1995 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/06/1994 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/08/1992 SUPPL-16 Labeling

Label is not available on this site.

09/11/1992 SUPPL-13 Labeling

Label is not available on this site.

09/28/1990 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/05/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/01/1990 SUPPL-10 Labeling

Label is not available on this site.

06/07/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/07/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/17/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/11/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/11/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/06/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/06/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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