ANDA 207762

ZYDUS PHARMS

FDA Drug Application

Application #207762

Application Sponsors

ANDA 207762

ZYDUS PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007
• Prescription: 008
• Prescription: 009
• Prescription: 010
• Prescription: 011

Application Products

001	TABLET;ORAL	EQ 2.5MG BASE;EQ 10MG BASE	0	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
002	TABLET;ORAL	EQ 2.5MG BASE;EQ 20MG BASE	0	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
003	TABLET;ORAL	EQ 2.5MG BASE;EQ 40MG BASE	0	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
004	TABLET;ORAL	EQ 5MG BASE;EQ 10MG BASE	0	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
005	TABLET;ORAL	EQ 5MG BASE;EQ 20MG BASE	0	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
006	TABLET;ORAL	EQ 5MG BASE;EQ 40MG BASE	0	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
007	TABLET;ORAL	EQ 5MG BASE;EQ 80MG BASE	0	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
008	TABLET;ORAL	EQ 10MG BASE;EQ 10MG BASE	0	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
009	TABLET;ORAL	EQ 10MG BASE;EQ 20MG BASE	0	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
010	TABLET;ORAL	EQ 10MG BASE;EQ 40MG BASE	0	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
011	TABLET;ORAL	EQ 10MG BASE;EQ 80MG BASE	0	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-01-11

STANDARD

Submissions Property Types

ORIG

1

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
009	Prescription	AB
010	Prescription	AB
011	Prescription	AB

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207762
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM","activeIngredients":"AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM","strength":"EQ 2.5MG 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 2.5MG 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 2.5MG 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 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":"01\/11\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-11
        )

)