ANDA 075300

BEXIMCO PHARMS USA

FDA Drug Application

Application #075300

Documents

• Letter: 2004-06-28

Application Sponsors

ANDA 075300

BEXIMCO PHARMS USA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	10MG	0	LOVASTATIN	LOVASTATIN
002	TABLET;ORAL	20MG	0	LOVASTATIN	LOVASTATIN
003	TABLET;ORAL	40MG	0	LOVASTATIN	LOVASTATIN

FDA Submissions

	ORIG	1	AP	2001-12-17
LABELING; Labeling	SUPPL	2	AP	2005-08-18
LABELING; Labeling	SUPPL	9	AP	2017-08-04	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-09-25	STANDARD

Submissions Property Types

SUPPL	9	Null	7
SUPPL	10	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

BEXIMCO PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75300
            [companyName] => BEXIMCO PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOVASTATIN","activeIngredients":"LOVASTATIN","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LOVASTATIN","activeIngredients":"LOVASTATIN","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LOVASTATIN","activeIngredients":"LOVASTATIN","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LOVASTATIN","submission":"LOVASTATIN","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LOVASTATIN","submission":"LOVASTATIN","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LOVASTATIN","submission":"LOVASTATIN","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)