Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040330
Company: VINTAGE PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;2.5MG TABLET;ORAL Prescription AA No Yes
PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Prescription AA No Yes
PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG TABLET;ORAL Prescription AA No Yes
PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG TABLET;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/25/1999 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40330ltr..pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40-330_Oxycodone%20and%20Acetaminophen.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/21/2018 SUPPL-52 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-50 REMS - PROPOSAL - D-N-A

Label is not available on this site.

12/16/2016 SUPPL-45 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-44 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Patient Package Insert

Label is not available on this site.

12/16/2016 SUPPL-43 Labeling-Package Insert

Label is not available on this site.

10/18/2013 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

04/10/2012 SUPPL-31 Labeling-Container/Carton Labels

Label is not available on this site.

06/28/2011 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

11/30/2006 SUPPL-15 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/040330s015,040341s013,040434s003lbl.pdf
03/16/2004 SUPPL-14 Labeling

Label is not available on this site.

07/31/2002 SUPPL-7 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

10/18/2001 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

04/12/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/2000 SUPPL-4 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

04/12/2000 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

11/02/1999 SUPPL-2 Labeling

Label is not available on this site.

04/12/2000 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/30/2006 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/040330s015,040341s013,040434s003lbl.pdf

PERCOCET

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 MALTA
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 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 MALTA
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 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 MALTA
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 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

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