Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202662
Company: EPIC PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB No No
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB No No
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription AB No No
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription AB No No
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 20MG 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
09/22/2015 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202662Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202662Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-5 REMS - PROPOSAL - D-N-A

Label is not available on this site.

04/27/2017 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/22/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202662Orig1s000lbl.pdf

OXYCODONE HYDROCHLORIDE

TABLET;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 TABLET;ORAL Prescription No AB 076636 ACTAVIS ELIZABETH
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202116 ALVOGEN
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 203638 AMNEAL PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202160 AUROLIFE PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 091393 AVANTHI INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090895 EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202662 EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 091313 MAYNE PHARMA INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 077290 NESHER PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 204021 NOVEL LABS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 207119 NUVO PHARM
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 091490 RHODES PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 076758 SPECGX LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090659 SUN PHARM INDS INC
ROXICODONE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 021011 SPECGX LLC

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 203638 AMNEAL PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 091393 AVANTHI INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 202662 EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 091313 MAYNE PHARMA INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 077290 NESHER PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 204021 NOVEL LABS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 207119 NUVO PHARM
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 091490 RHODES PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090659 SUN PHARM INDS INC

TABLET;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 076636 ACTAVIS ELIZABETH
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 202116 ALVOGEN
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 203638 AMNEAL PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 207418 ASCENT PHARMS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 202160 AUROLIFE PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 091393 AVANTHI INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 090895 EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 202662 EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 091313 MAYNE PHARMA INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 077290 NESHER PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 204021 NOVEL LABS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 207119 NUVO PHARM
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 091490 RHODES PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 076758 SPECGX LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 090659 SUN PHARM INDS INC
ROXICODONE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription Yes AB 021011 SPECGX LLC

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 076636 ACTAVIS ELIZABETH
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 202116 ALVOGEN
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 203638 AMNEAL PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 207418 ASCENT PHARMS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 202160 AUROLIFE PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 091393 AVANTHI INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 090895 EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 202662 EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 091313 MAYNE PHARMA INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 077290 NESHER PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 204021 NOVEL LABS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 207119 NUVO PHARM
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 091490 RHODES PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 076758 SPECGX LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 090659 SUN PHARM INDS INC
ROXICODONE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription Yes AB 021011 SPECGX LLC

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 203638 AMNEAL PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 091393 AVANTHI INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 202662 EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 091313 MAYNE PHARMA INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 077290 NESHER PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 204021 NOVEL LABS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 207119 NUVO PHARM
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 091490 RHODES PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 090659 SUN PHARM INDS INC

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