Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075135
Company: UPSHER SMITH LABS

• Medication Guide

• Other Important Information from FDA

Products on ANDA 75135

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PACERONE	AMIODARONE HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	AB	No	No
PACERONE	AMIODARONE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	AB	No	No
PACERONE	AMIODARONE HYDROCHLORIDE	400MG	TABLET;ORAL	Prescription	AB	No	No

Labels for ANDA 075135

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135ap_appltr_prntlbl_chemr.pdf