Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040409
Company: MALLINCKRODT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANEXSIA 5/325 ACETAMINOPHEN; HYDROCODONE BITARTRATE 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
10/20/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40409ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/20/2017 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-23 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

10/25/2013 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

06/24/2011 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

09/15/2010 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

03/27/2006 SUPPL-11 Labeling

Label is not available on this site.

10/10/2003 SUPPL-6 Labeling

Label is not available on this site.

11/13/2002 SUPPL-4 Labeling

Label is not available on this site.

08/26/2002 SUPPL-3 Labeling

Label is not available on this site.

08/08/2002 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/2001 SUPPL-1 Labeling

Label is not available on this site.

ANEXSIA 5/325

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANEXSIA 5/325 ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET;ORAL Prescription No AA 040409 MALLINCKRODT
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET;ORAL Prescription No AA 209037 ABHAI LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET;ORAL Prescription No AA 040736 AMNEAL PHARMS NY
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET;ORAL Prescription No AA 201013 AUROLIFE PHARMA LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET;ORAL Prescription No AA 207172 LANNETT HOLDINGS INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET;ORAL Prescription No AA 202935 LARKEN LABS INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET;ORAL Prescription No AA 206245 NOVEL LABS INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET;ORAL Prescription No AA 202991 RHODES PHARMS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET;ORAL Prescription No AA 090118 SUN PHARM INDS INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET;ORAL Prescription No AA 202214 TRIS PHARMA INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET;ORAL Prescription No AA 206484 UPSHER-SMITH LABS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET;ORAL Prescription No AA 040655 VINTAGE PHARMS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET;ORAL Prescription No AA 210211 WES PHARMA INC
NORCO ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET;ORAL Prescription No AA 040099 APIL
NORCO ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET;ORAL Prescription No AA 040148 APIL

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