ANDA 091144

CIPLA

FDA Drug Application

Application #091144

Documents

• Letter: 2012-02-02

Application Sponsors

ANDA 091144

CIPLA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 600MG BASE;300MG

0

ABACAVIR SULFATE AND LAMIVUDINE

ABACAVIR SULFATE; LAMIVUDINE

FDA Submissions

	ORIG	1	AP	2017-03-28
LABELING; Labeling	SUPPL	13	AP	2019-07-25	STANDARD
LABELING; Labeling	SUPPL	15	AP	2019-07-25	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	13	Null	7
SUPPL	15	Null	15

TE Codes

001

Prescription

AB

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91144
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABACAVIR SULFATE AND LAMIVUDINE","activeIngredients":"ABACAVIR SULFATE; LAMIVUDINE","strength":"EQ 600MG BASE;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ABACAVIR SULFATE AND LAMIVUDINE","submission":"ABACAVIR SULFATE; LAMIVUDINE","actionType":"EQ 600MG BASE;300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)