ANDA 200491

ANCHEN PHARMS

FDA Drug Application

Application #200491

Application Sponsors

ANDA 200491

ANCHEN PHARMS

Marketing Status

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

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	100MG	0	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	200MG	0	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	300MG	0	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-06-27
LABELING; Labeling	SUPPL	4	AP	2015-10-30	STANDARD
LABELING; Labeling	SUPPL	5	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	7	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	8	AP	2017-08-29	STANDARD
REMS; REMS	SUPPL	10	AP	2018-09-18
LABELING; Labeling	SUPPL	11	AP	2018-09-21	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-10-11	STANDARD
LABELING; Labeling	SUPPL	14	AP	2021-03-04	STANDARD
LABELING; Labeling	SUPPL	16	AP	2021-09-10	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	14	Null	7
SUPPL	16	Null	15

TE Codes

001	Prescription	AB2
002	Prescription	AB2
003	Prescription	AB2

CDER Filings

ANCHEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200491
            [companyName] => ANCHEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAMADOL HYDROCHLORIDE","activeIngredients":"TRAMADOL HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRAMADOL HYDROCHLORIDE","activeIngredients":"TRAMADOL HYDROCHLORIDE","strength":"200MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRAMADOL HYDROCHLORIDE","activeIngredients":"TRAMADOL HYDROCHLORIDE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/27\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/10\/2021","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/04\/2021","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/11\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/21\/2018","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2018","submission":"SUPPL-10","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/29\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/16\/2016","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/16\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/30\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-09-10
        )

)