ANDA 078065

NORTEC DEV ASSOC

FDA Drug Application

Application #078065

Documents

• Letter: 2007-01-31
• Label: 2007-01-31

Application Sponsors

ANDA 078065

NORTEC DEV ASSOC

Marketing Status

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

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	60MG	0	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE
002	CAPSULE, EXTENDED RELEASE;ORAL	80MG	0	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE
003	CAPSULE, EXTENDED RELEASE;ORAL	120MG	0	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE
004	CAPSULE, EXTENDED RELEASE;ORAL	160MG	0	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2007-01-26
LABELING; Labeling	SUPPL	4	AP	2015-04-13

Submissions Property Types

ORIG	1	Null	1
SUPPL	4	Null	15

TE Codes

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

CDER Filings

NORTEC DEV ASSOC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78065
            [companyName] => NORTEC DEV ASSOC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPRANOLOL HYDROCHLORIDE","activeIngredients":"PROPRANOLOL HYDROCHLORIDE","strength":"60MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROPRANOLOL HYDROCHLORIDE","activeIngredients":"PROPRANOLOL HYDROCHLORIDE","strength":"80MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROPRANOLOL HYDROCHLORIDE","activeIngredients":"PROPRANOLOL HYDROCHLORIDE","strength":"120MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROPRANOLOL HYDROCHLORIDE","activeIngredients":"PROPRANOLOL HYDROCHLORIDE","strength":"160MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/26\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/078065lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PROPRANOLOL HYDROCHLORIDE","submission":"PROPRANOLOL HYDROCHLORIDE","actionType":"60MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PROPRANOLOL HYDROCHLORIDE","submission":"PROPRANOLOL HYDROCHLORIDE","actionType":"80MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PROPRANOLOL HYDROCHLORIDE","submission":"PROPRANOLOL HYDROCHLORIDE","actionType":"120MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PROPRANOLOL HYDROCHLORIDE","submission":"PROPRANOLOL HYDROCHLORIDE","actionType":"160MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2007-01-26
        )

)