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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091675
Company: TRIS PHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 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
06/28/2012 ORIG-1 Approval

Label is not available on this site.

PROMETHAZINE HYDROCHLORIDE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 040026 AKORN
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 040882 AMNEAL PHARMS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 040891 NOSTRUM LABS INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 040643 PHARM ASSOC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 213890 QUAGEN
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 040718 TARO
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription No AA 091675 TRIS PHARMA INC
PROMETHAZINE PLAIN PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP;ORAL Prescription Yes AA 087953 WOCKHARDT BIO AG
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