Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203208
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML 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
07/12/2013 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
09/18/2018 SUPPL-4 REMS - PROPOSAL - D-N-A

Label is not available on this site.

09/04/2014 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

OXYCODONE HYDROCHLORIDE

SOLUTION;ORAL; 100MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 208593 ABHAI LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 211749 ALKEM LABS LTD
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 203447 ANI PHARMS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 209021 ASCENT PHARMS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription Yes AA 200535 GENUS LIFESCIENCES
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 208795 HI TECH
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 204092 MAYNE PHARMA INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 204603 NOVEL LABS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 206822 PHARM ASSOC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 210758 SPECGX LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 202537 VISTAPHARM
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 209897 WES PHARMA INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 203208 WEST-WARD PHARMS INT

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