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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208653
Company: ZEVRA THERAP

Medication Guide

REMS

Products on NDA 208653

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
APADAZ	ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE	325MG;EQ 6.12MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
APADAZ	ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE	325MG;EQ 4.08MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
APADAZ	ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE	325MG;EQ 8.16MG BASE	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208653

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/23/2018	ORIG-1	Approval	Type 4 - New Combination	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208653s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208653Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208653Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208653s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208653Orig1s008ltr.pdf
03/04/2021	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208653s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208653Orig1s007ltr.pdf
10/07/2019	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208653s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208653Orig1s005ltr.pdf
09/18/2018	SUPPL-3	REMS - PROPOSAL - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208653s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208653Orig1s002s003ltr.pdf
09/18/2018	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208653s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208653Orig1s002s003ltr.pdf

Labels for NDA 208653

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208653s008lbl.pdf
03/04/2021	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208653s007lbl.pdf
10/07/2019	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208653s005lbl.pdf
10/07/2019	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208653s005lbl.pdf
09/18/2018	SUPPL-3	REMS - PROPOSAL - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208653s002s003lbl.pdf
09/18/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208653s002s003lbl.pdf
02/23/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208653s000lbl.pdf

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