Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021496
Company: AMPHASTAR PHARMS INC

Products on NDA 21496

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DUOCAINE	BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE	EQ 0.375% (37.5MG/10ML);EQ 1% (100MG/10ML)	INJECTABLE;INJECTION	Discontinued	None	No	No

Labels for NDA 021496

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/23/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21496_duocaine_lbl.pdf