Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040656
Company: VINTAGE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG 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
01/19/2006 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
10/11/2019 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

10/11/2019 SUPPL-29 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-25 REMS - PROPOSAL - D-N-A

Label is not available on this site.

12/16/2016 SUPPL-24 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-22 Labeling-Container/Carton Labels

Label is not available on this site.

12/16/2016 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

12/15/2016 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

12/15/2016 SUPPL-15 Labeling-Container/Carton Labels, Labeling-Patient Package Insert

Label is not available on this site.

10/22/2013 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

07/01/2011 SUPPL-5 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

04/07/2008 SUPPL-1 Labeling

Label is not available on this site.

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

TABLET;ORAL; 325MG;7.5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANEXSIA 7.5/325 ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 040405 SPECGX LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 209037 ABHAI LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 040746 AMNEAL PHARMS NY
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 040432 ANDA REPOSITORY
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 211487 ASCENT PHARMS INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 201013 AUROLIFE PHARMA LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 203863 EPIC PHARMA LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 206245 NOVEL LABS INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 202935 PAR PHARM
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 202991 RHODES PHARMS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 090118 SUN PHARM INDS INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 202214 TRIS PHARMA INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 040656 VINTAGE PHARMS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 210211 WES PHARMA INC
NORCO ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription No AA 040148 APIL

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