Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 211023
Company: WES PHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG/15ML;7.5MG/15ML SOLUTION;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
03/08/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

SOLUTION;ORAL; 325MG/15ML;7.5MG/15ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG/15ML;7.5MG/15ML SOLUTION;ORAL Prescription No AA 040482 ANDA REPOSITORY
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG/15ML;7.5MG/15ML SOLUTION;ORAL Prescription No AA 040894 GENUS LIFESCIENCES
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG/15ML;7.5MG/15ML SOLUTION;ORAL Prescription No AA 040838 PHARM ASSOC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG/15ML;7.5MG/15ML SOLUTION;ORAL Prescription No AA 200343 VISTAPHARM
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG/15ML;7.5MG/15ML SOLUTION;ORAL Prescription No AA 211023 WES PHARMA INC

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