Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090964
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB No No
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET;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
09/27/2010 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-6 REMS - PROPOSAL - D-N-A

Label is not available on this site.

08/25/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

OXYMORPHONE HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OPANA OXYMORPHONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 021611 ENDO PHARMS
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 210175 ASCENT PHARMS INC
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 204459 AUROLIFE PHARMA LLC
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 203601 AVANTHI INC
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 201187 EPIC PHARMA LLC
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090964 HIKMA
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202321 SPECGX LLC
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 091443 TEVA

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OPANA OXYMORPHONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription Yes AB 021611 ENDO PHARMS
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 210175 ASCENT PHARMS INC
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 204459 AUROLIFE PHARMA LLC
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 203601 AVANTHI INC
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 201187 EPIC PHARMA LLC
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090964 HIKMA
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 202321 SPECGX LLC
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 091443 TEVA

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