ANDA 202688

WATSON LABS INC

FDA Drug Application

Application #202688

Documents

• Letter: 2015-08-28
• Label: 2015-10-15

Application Sponsors

ANDA 202688

WATSON LABS INC

Marketing Status

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

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	225MG	0	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE
002	CAPSULE, EXTENDED RELEASE;ORAL	325MG	0	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE
003	CAPSULE, EXTENDED RELEASE;ORAL	425MG	0	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-08-24
LABELING; Labeling	SUPPL	4	AP	2019-10-30	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202688
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPAFENONE HYDROCHLORIDE","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"225MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROPAFENONE HYDROCHLORIDE","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"325MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROPAFENONE HYDROCHLORIDE","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"425MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/24\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202688Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/24\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202688Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202688Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/30\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-30
        )

)