Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020997
Company: PURDUE PHARMA LP

Products on NDA 020997

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHIROCAINE	LEVOBUPIVACAINE HYDROCHLORIDE	EQ 2.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No
CHIROCAINE	LEVOBUPIVACAINE HYDROCHLORIDE	EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No
CHIROCAINE	LEVOBUPIVACAINE HYDROCHLORIDE	EQ 7.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020997

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/05/1999	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20997lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20997ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20997_Chirocaine.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/30/2002	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
12/02/1999	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020997

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/05/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20997lbl.pdf