NDA 020997

PURDUE PHARMA LP

FDA Drug Application

Application #020997

Documents

• Letter: 1999-08-05
• Label: 1999-08-05
• Review: 1999-08-05

Application Sponsors

NDA 020997

PURDUE PHARMA LP

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	INJECTABLE;INJECTION	EQ 2.5MG BASE/ML	0	CHIROCAINE	LEVOBUPIVACAINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 5MG BASE/ML	0	CHIROCAINE	LEVOBUPIVACAINE HYDROCHLORIDE
003	INJECTABLE;INJECTION	EQ 7.5MG BASE/ML	0	CHIROCAINE	LEVOBUPIVACAINE HYDROCHLORIDE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1999-08-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-08-30	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	6	Null	0

CDER Filings

PURDUE PHARMA LP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20997
            [companyName] => PURDUE PHARMA LP
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHIROCAINE","activeIngredients":"LEVOBUPIVACAINE HYDROCHLORIDE","strength":"EQ 2.5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CHIROCAINE","activeIngredients":"LEVOBUPIVACAINE HYDROCHLORIDE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CHIROCAINE","activeIngredients":"LEVOBUPIVACAINE HYDROCHLORIDE","strength":"EQ 7.5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/05\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20997lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CHIROCAINE","submission":"LEVOBUPIVACAINE HYDROCHLORIDE","actionType":"EQ 2.5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CHIROCAINE","submission":"LEVOBUPIVACAINE HYDROCHLORIDE","actionType":"EQ 5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CHIROCAINE","submission":"LEVOBUPIVACAINE HYDROCHLORIDE","actionType":"EQ 7.5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1999-08-05
        )

)