ANDA 075964

SUN PHARM INDS INC

FDA Drug Application

Application #075964

Documents

• Label: 2002-06-19
• Letter: 2002-06-19

Application Sponsors

ANDA 075964

SUN PHARM INDS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG

0

TRAMADOL HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2002-06-19
LABELING; Labeling	SUPPL	2	AP	2003-06-16
LABELING; Labeling	SUPPL	5	AP	2002-09-27
LABELING; Labeling	SUPPL	16	AP	2010-11-22
LABELING; Labeling	SUPPL	25	AP	2015-10-15	STANDARD
LABELING; Labeling	SUPPL	27	AP	2022-09-06	STANDARD
LABELING; Labeling	SUPPL	29	AP	2022-09-06	STANDARD
REMS; REMS	SUPPL	31	AP	2018-09-18
LABELING; Labeling	SUPPL	32	AP	2022-09-06	STANDARD
LABELING; Labeling	SUPPL	35	AP	2022-09-06	STANDARD
LABELING; Labeling	SUPPL	36	AP	2022-09-06	STANDARD
LABELING; Labeling	SUPPL	41	AP	2022-09-06	STANDARD
LABELING; Labeling	SUPPL	42	AP	2022-09-06	STANDARD

Submissions Property Types

SUPPL	16	Null	8
SUPPL	25	Null	15
SUPPL	27	Null	15
SUPPL	29	Null	31
SUPPL	31	Null	7
SUPPL	32	Null	15
SUPPL	35	Null	7
SUPPL	36	Null	7
SUPPL	41	Null	7
SUPPL	42	Null	7

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75964
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAMADOL HYDROCHLORIDE","activeIngredients":"TRAMADOL HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/19\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/N75964lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TRAMADOL HYDROCHLORIDE","submission":"TRAMADOL HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2002-06-19
        )

)