Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 087003
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROXICET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;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
02/25/1980 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
09/21/2018 SUPPL-42 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-41 REMS - PROPOSAL - D-N-A

Label is not available on this site.

12/16/2016 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-38 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

08/12/2014 SUPPL-36 Labeling-Container/Carton Labels

Label is not available on this site.

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

Label is not available on this site.

06/28/2011 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

08/29/2007 SUPPL-27 Labeling

Label is not available on this site.

06/05/2001 SUPPL-20 Labeling

Label is not available on this site.

03/22/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/19/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/23/1993 SUPPL-16 Labeling

Label is not available on this site.

05/13/1993 SUPPL-15 Labeling

Label is not available on this site.

09/15/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/29/1991 SUPPL-13 Labeling

Label is not available on this site.

10/21/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/21/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/21/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/29/1989 SUPPL-9 Labeling

Label is not available on this site.

02/01/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/01/1991 SUPPL-7 Labeling

Label is not available on this site.

02/01/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/29/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/01/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

ROXICET

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

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