Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040660
Company: VINTAGE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;5MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription AA 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
12/07/2006 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
06/26/2018 SUPPL-22 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/29/2017 SUPPL-20 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/13/2017 SUPPL-19 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/10/2013 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

08/27/2009 SUPPL-5 Labeling

Label is not available on this site.

12/19/2008 SUPPL-2 Labeling

Label is not available on this site.

02/25/2008 SUPPL-1 Labeling

Label is not available on this site.

PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE

SYRUP;ORAL; 10MG/5ML;5MG/5ML;6.25MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;5MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 040660 VINTAGE
PROMETH VC W/ CODEINE CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;5MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 088764 ACTAVIS MID ATLANTIC
PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;5MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 040674 HI-TECH PHARMA CO
PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;5MG/5ML;6.25MG/5ML SYRUP;ORAL Prescription No AA 200963 AMNEAL PHARMS

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