NDA 021496

AMPHASTAR PHARMS INC

FDA Drug Application

Application #021496

Documents

• Review: 2003-11-06
• Letter: 2003-06-08
• Label: 2003-09-17

Application Sponsors

NDA 021496

AMPHASTAR PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 0.375% (37.5MG/10ML);EQ 1% (100MG/10ML)

0

DUOCAINE

BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

AP

2003-05-23

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

AMPHASTAR PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21496
            [companyName] => AMPHASTAR PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DUOCAINE","activeIngredients":"BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE","strength":"EQ 0.375% (37.5MG\/10ML);EQ 1% (100MG\/10ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/23\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21496_duocaine_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DUOCAINE","submission":"BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE","actionType":"EQ 0.375% (37.5MG\/10ML);EQ 1% (100MG\/10ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2003-05-23
        )

)