Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090733
Company: VINTAGE PHARMS
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/11/2013 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
10/07/2019 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-14 REMS - PROPOSAL - D-N-A

Label is not available on this site.

12/16/2016 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

10/18/2013 SUPPL-1 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English