ANDA 205234

ALEMBIC PHARMS LTD

FDA Drug Application

Application #205234

Documents

• Letter: 2016-12-06

Application Sponsors

ANDA 205234

ALEMBIC PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	EQ 5MG BASE;40MG	0	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN
002	TABLET;ORAL	EQ 10MG BASE;40MG	0	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN
003	TABLET;ORAL	EQ 5MG BASE;80MG	0	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN
004	TABLET;ORAL	EQ 10MG BASE;80MG	0	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-11-17

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205234
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TELMISARTAN AND AMLODIPINE","activeIngredients":"AMLODIPINE BESYLATE; TELMISARTAN","strength":"EQ 5MG BASE;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TELMISARTAN AND AMLODIPINE","activeIngredients":"AMLODIPINE BESYLATE; TELMISARTAN","strength":"EQ 10MG BASE;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TELMISARTAN AND AMLODIPINE","activeIngredients":"AMLODIPINE BESYLATE; TELMISARTAN","strength":"EQ 5MG BASE;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TELMISARTAN AND AMLODIPINE","activeIngredients":"AMLODIPINE BESYLATE; TELMISARTAN","strength":"EQ 10MG BASE;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/17\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205234Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-11-17
        )

)