Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090535
Company: SUN PHARM INDS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;2.5MG TABLET;ORAL Prescription AA No No
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription AA No No
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription AA No No
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;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
12/26/2013 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
09/20/2018 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-10 REMS - PROPOSAL - D-N-A

Label is not available on this site.

12/16/2016 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-5 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

OXYCODONE AND ACETAMINOPHEN

TABLET;ORAL; 325MG;2.5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;2.5MG TABLET;ORAL Prescription No AA 210644 ABHAI LLC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;2.5MG TABLET;ORAL Prescription No AA 201447 ACTAVIS ELIZABETH
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;2.5MG TABLET;ORAL Prescription No AA 207419 ASCENT PHARMS INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;2.5MG TABLET;ORAL Prescription No AA 201972 AUROLIFE PHARMA LLC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;2.5MG TABLET;ORAL Prescription No AA 090177 MAYNE PHARMA INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;2.5MG TABLET;ORAL Prescription No AA 210079 NESHER PHARMS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;2.5MG TABLET;ORAL Prescription No AA 204407 NOVEL LABS INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;2.5MG TABLET;ORAL Prescription No AA 090535 SUN PHARM INDS INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;2.5MG TABLET;ORAL Prescription No AA 090733 VINTAGE PHARMS
PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;2.5MG TABLET;ORAL Prescription No AA 040330 VINTAGE PHARMS LLC

TABLET;ORAL; 325MG;5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 087463 SPECGX LLC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 210644 ABHAI LLC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 201447 ACTAVIS ELIZABETH
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 202677 ALVOGEN
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 040777 AMNEAL PHARMS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 207419 ASCENT PHARMS INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 201972 AUROLIFE PHARMA LLC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 207574 CHEMO RESEARCH SL
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 209385 ELITE LABS INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 203864 EPIC PHARMA LLC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 207834 HALO PHARM CANADA
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 207333 LANNETT CO INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 090177 MAYNE PHARMA INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 210079 NESHER PHARMS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 204407 NOVEL LABS INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 201278 RHODES PHARMS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 090535 SUN PHARM INDS INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 040105 VINTAGE PHARMS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 040171 WATSON LABS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 207510 WES PHARMA INC
PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 040330 VINTAGE PHARMS LLC
ROXICET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 087003 WEST-WARD PHARMS INT

TABLET;ORAL; 325MG;7.5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription No AA 210644 ABHAI LLC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription No AA 201447 ACTAVIS ELIZABETH
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription No AA 202677 ALVOGEN
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription No AA 040778 AMNEAL PHARMS NY
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription No AA 207419 ASCENT PHARMS INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription No AA 201972 AUROLIFE PHARMA LLC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription No AA 209385 ELITE LABS INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription No AA 203864 EPIC PHARMA LLC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription No AA 207834 HALO PHARM CANADA
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription No AA 090177 MAYNE PHARMA INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription No AA 210079 NESHER PHARMS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription No AA 204407 NOVEL LABS INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription No AA 201278 RHODES PHARMS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription No AA 040545 SPECGX LLC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription No AA 090535 SUN PHARM INDS INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription No AA 090734 VINTAGE PHARMS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription No AA 040535 WATSON LABS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription No AA 207510 WES PHARMA INC
PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription No AA 040330 VINTAGE PHARMS LLC

TABLET;ORAL; 325MG;10MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 210644 ABHAI LLC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 201447 ACTAVIS ELIZABETH
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 202677 ALVOGEN
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 040778 AMNEAL PHARMS NY
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 207419 ASCENT PHARMS INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 201972 AUROLIFE PHARMA LLC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 209385 ELITE LABS INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 203864 EPIC PHARMA LLC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 207834 HALO PHARM CANADA
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 207333 LANNETT CO INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 090177 MAYNE PHARMA INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 210079 NESHER PHARMS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 204407 NOVEL LABS INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 201278 RHODES PHARMS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 040545 SPECGX LLC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 090535 SUN PHARM INDS INC
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 090734 VINTAGE PHARMS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 040535 WATSON LABS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 207510 WES PHARMA INC
PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 040330 VINTAGE PHARMS LLC

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