Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208817
Company: HI TECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/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
08/10/2017 ORIG-1 Approval STANDARD

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-1 REMS - PROPOSAL - D-N-A

Label is not available on this site.

OXYCODONE HYDROCHLORIDE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 208593 ABHAI LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 211748 ALKEM LABS LTD
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 204979 ANI PHARMS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 209021 ASCENT PHARMS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription Yes AA 200535 GENUS LIFESCIENCES
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 208817 HI TECH
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 206914 PHARM ASSOC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 210758 SPECGX LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription Yes AA 201194 VISTAPHARM
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 207511 WES PHARMA INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 204037 WEST-WARD PHARMS INT
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 206456 WOCKHARDT BIO AG

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