ANDA 205199

APOTEX

FDA Drug Application

Application #205199

Application Sponsors

ANDA 205199

APOTEX

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007
• Prescription: 008

Application Products

001	TABLET;ORAL	EQ 5MG BASE;EQ 10MG BASE	0	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
002	TABLET;ORAL	EQ 5MG BASE;EQ 20MG BASE	0	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
003	TABLET;ORAL	EQ 5MG BASE;EQ 40MG BASE	0	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
004	TABLET;ORAL	EQ 5MG BASE;EQ 80MG BASE	0	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
005	TABLET;ORAL	EQ 10MG BASE;EQ 10MG BASE	0	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
006	TABLET;ORAL	EQ 10MG BASE;EQ 20MG BASE	0	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
007	TABLET;ORAL	EQ 10MG BASE;EQ 40MG BASE	0	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
008	TABLET;ORAL	EQ 10MG BASE;EQ 80MG BASE	0	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-11-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-09-27	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-09-27	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-09-27	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB
007	Prescription	AB
008	Prescription	AB

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205199
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM","activeIngredients":"AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM","strength":"EQ 5MG BASE;EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM","activeIngredients":"AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM","strength":"EQ 5MG BASE;EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM","activeIngredients":"AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM","strength":"EQ 5MG BASE;EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM","activeIngredients":"AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM","strength":"EQ 5MG BASE;EQ 80MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM","activeIngredients":"AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM","strength":"EQ 10MG BASE;EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM","activeIngredients":"AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM","strength":"EQ 10MG BASE;EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM","activeIngredients":"AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM","strength":"EQ 10MG BASE;EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM","activeIngredients":"AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM","strength":"EQ 10MG BASE;EQ 80MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/18\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-18
        )

)