ANDA 212026

AMTA

FDA Drug Application

Application #212026

Application Sponsors

ANDA 212026

AMTA

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

UNKNOWN;

ORIG

1

AP

2020-01-06

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

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

CDER Filings

AMTA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212026
            [companyName] => AMTA
            [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] => 
            [originalApprovals] => [{"actionDate":"01\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-01-06
        )

)