Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 211487
Company: ASCENT PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;2.5MG TABLET;ORAL Prescription AA No No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET;ORAL Prescription AA No No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET;ORAL Prescription AA No No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG 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
11/07/2018 ORIG-1 Approval STANDARD

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-1 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

HYDROCODONE BITARTRATE 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
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;2.5MG TABLET;ORAL Prescription No AA 040846 ANDA REPOSITORY
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;2.5MG TABLET;ORAL Prescription No AA 211487 ASCENT PHARMS INC
NORCO ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;2.5MG TABLET;ORAL Prescription No AA 040148 APIL

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 SPECGX LLC
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 211487 ASCENT PHARMS INC
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 203863 EPIC PHARMA LLC
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 202935 PAR PHARM
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 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

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

TABLET;ORAL; 325MG;10MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 209037 ABHAI LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 040746 AMNEAL PHARMS NY
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 211487 ASCENT PHARMS INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 201013 AUROLIFE PHARMA LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 203863 EPIC PHARMA LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 206245 NOVEL LABS INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 202935 PAR PHARM
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 202991 RHODES PHARMS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 040400 SPECGX LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 090118 SUN PHARM INDS INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 202214 TRIS PHARMA INC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 040355 VINTAGE PHARMS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 210211 WES PHARMA INC
NORCO ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET;ORAL Prescription No AA 040148 APIL

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