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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201187
Company: EPIC PHARMA LLC
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
12/15/2014 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2021 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/16/2021 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/16/2021 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-4 REMS - PROPOSAL - D-N-A

Label is not available on this site.

02/16/2021 SUPPL-2 Labeling-Medication Guide, 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
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
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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