NDA 019891

RHODES PHARMS

FDA Drug Application

Application #019891

Documents

• Label: 2006-06-12
• 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 019891

RHODES PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

5MG/5ML

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	1999-11-24	STANDARD
LABELING; Labeling	SUPPL	4	AP	2001-08-22	STANDARD
LABELING; Labeling	SUPPL	8	AP	2006-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2013-11-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2015-02-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2015-03-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2016-02-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2016-02-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2016-02-05	STANDARD
LABELING; Labeling	SUPPL	24	AP	2016-12-16	STANDARD
REMS; REMS	SUPPL	26	AP	2018-09-18	N/A
LABELING; Labeling	SUPPL	27	AP	2018-09-18	STANDARD
LABELING; Labeling	SUPPL	28	AP	2019-10-07	STANDARD
LABELING; Labeling	SUPPL	29	AP	2021-03-04	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	15
SUPPL	26	Null	7
SUPPL	27	Null	15
SUPPL	28	Null	6
SUPPL	29	Null	6

TE Codes

001

Prescription

AA

CDER Filings

RHODES PHARMS

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(
    [0] => Array
        (
            [ApplNo] => 19891
            [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":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-28","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-28","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-27","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-26","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-24","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-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019891s024,019892s029lbl.pdf\"}]","notes":""},{"actionDate":"06\/12\/2006","submission":"SUPPL-8","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":"5MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-07
        )

)