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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201278
Company: RHODES PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
08/28/2014 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201278Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2021 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

10/08/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

10/23/2018 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

10/12/2018 SUPPL-7 Labeling-Container/Carton Labels

Label is not available on this site.

09/18/2018 SUPPL-6 REMS - PROPOSAL - D-N-A

Label is not available on this site.

02/10/2017 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/10/2017 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/10/2017 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

OXYCODONE AND ACETAMINOPHEN

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 207834 CHARTWELL
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 090177 MAYNE PHARMA INC
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 207510 WES PHARMA INC
PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription No AA 040330 VINTAGE PHARMS LLC

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 207834 CHARTWELL
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 090177 MAYNE PHARMA INC
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 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 207834 CHARTWELL
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 090177 MAYNE PHARMA INC
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 207510 WES PHARMA INC
PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription No AA 040330 VINTAGE PHARMS LLC
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