NDA 019892

RHODES PHARMS

FDA Drug Application

Application #019892

Documents

• Letter: 2004-06-02
• Letter: 2007-11-19
• Label: 2006-06-12
• Label: 2007-11-19
• Letter: 2006-06-12
• Letter: 2016-12-20
• Label: 2016-12-21
• Label: 2018-09-24
• Label: 2018-09-24
• Letter: 2018-09-28
• Letter: 2018-09-28
• Label: 2019-10-08
• Medication Guide: 2019-10-08
• Letter: 2019-10-08
• Letter: 2021-03-05
• Label: 2021-03-05
• Medication Guide: 2021-03-05

Application Sponsors

NDA 019892

RHODES PHARMS

Marketing Status

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

Application Products

001	TABLET;ORAL	8MG	1	DILAUDID	HYDROMORPHONE HYDROCHLORIDE
002	TABLET;ORAL	4MG	1	DILAUDID	HYDROMORPHONE HYDROCHLORIDE
003	TABLET;ORAL	2MG	1	DILAUDID	HYDROMORPHONE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1992-12-07	STANDARD
LABELING; Labeling	SUPPL	2	AP	2003-03-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-02-24	STANDARD
LABELING; Labeling	SUPPL	4	AP	2001-08-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-04-12	STANDARD
LABELING; Labeling	SUPPL	9	AP	2006-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2007-11-09	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2013-01-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2012-12-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2013-07-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2015-01-26	STANDARD
LABELING; Labeling	SUPPL	29	AP	2016-12-16	STANDARD
REMS; REMS	SUPPL	33	AP	2018-09-18	N/A
LABELING; Labeling	SUPPL	34	AP	2018-09-18	STANDARD
LABELING; Labeling	SUPPL	35	AP	2019-10-07	STANDARD
LABELING; Labeling	SUPPL	37	AP	2021-03-04	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0
SUPPL	29	Null	6
SUPPL	33	Null	6
SUPPL	34	Null	7
SUPPL	35	Null	7
SUPPL	37	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

RHODES PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19892
            [companyName] => RHODES PHARMS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/019891s028,019892s035lbl.pdf#page=28"]
            [products] => [{"drugName":"DILAUDID","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DILAUDID","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"DILAUDID","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-35","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019891s028,019892s035lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019891s028,019892s035lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019891s026s027,019892s033s034lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-33","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019891s026s027,019892s033s034lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019891s024,019892s029lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019891s024,019892s029lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2007","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019892s015lbl.pdf\"}]","notes":""},{"actionDate":"06\/12\/2006","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/019892s009,019891s008lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DILAUDID","submission":"HYDROMORPHONE HYDROCHLORIDE","actionType":"8MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DILAUDID","submission":"HYDROMORPHONE HYDROCHLORIDE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DILAUDID","submission":"HYDROMORPHONE HYDROCHLORIDE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-07
        )

)