NDA 020198

ALVOGEN

FDA Drug Application

Application #020198

Documents

• Letter: 2005-04-06
• Letter: 2010-03-08
• Letter: 2011-03-02
• Label: 2005-04-06
• Label: 2010-03-05
• Label: 2011-02-28

Application Sponsors

NDA 020198

ALVOGEN

Marketing Status

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

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	30MG	1	ADALAT CC	NIFEDIPINE
002	TABLET, EXTENDED RELEASE;ORAL	60MG	1	ADALAT CC	NIFEDIPINE
003	TABLET, EXTENDED RELEASE;ORAL	90MG	1	ADALAT CC	NIFEDIPINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1993-04-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1993-12-06	STANDARD
LABELING; Labeling	SUPPL	3	AP	1994-07-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1994-07-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-03-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-06-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-01-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1996-03-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1996-07-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-12-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1999-04-13	STANDARD
LABELING; Labeling	SUPPL	17	AP	2005-04-01	STANDARD
LABELING; Labeling	SUPPL	22	AP	2010-03-03	STANDARD
LABELING; Labeling	SUPPL	23	AP	2011-02-28	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2015-03-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2016-05-17	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	22	Null	6
SUPPL	23	Null	6
SUPPL	24	Null	0
SUPPL	25	Null	0

TE Codes

001	Prescription	AB1
002	Prescription	AB1
003	Prescription	AB1

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20198
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADALAT CC","activeIngredients":"NIFEDIPINE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ADALAT CC","activeIngredients":"NIFEDIPINE","strength":"60MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ADALAT CC","activeIngredients":"NIFEDIPINE","strength":"90MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/28\/2011","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020198s023lbl.pdf\"}]","notes":""},{"actionDate":"03\/03\/2010","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020198s022lbl.pdf\"}]","notes":""},{"actionDate":"04\/01\/2005","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/20198s017lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ADALAT CC","submission":"NIFEDIPINE","actionType":"30MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ADALAT CC","submission":"NIFEDIPINE","actionType":"60MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ADALAT CC","submission":"NIFEDIPINE","actionType":"90MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2011-02-28
        )

)