Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202773
Company: AVANTHI INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG CAPSULE;ORAL Prescription AB 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
08/17/2015 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-2 REMS - PROPOSAL - D-N-A

Label is not available on this site.

OXYCODONE HYDROCHLORIDE

CAPSULE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG CAPSULE;ORAL Prescription No AB 205177 ANI PHARMS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG CAPSULE;ORAL Prescription No AB 202773 AVANTHI INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG CAPSULE;ORAL Prescription Yes AB 200534 GENUS LIFESCIENCES
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG CAPSULE;ORAL Prescription No AB 203823 LANNETT CO INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG CAPSULE;ORAL Prescription No AB 203107 MAYNE PHARMA INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG CAPSULE;ORAL Prescription No AB 204752 NOVEL LABS INC

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