01 5Actavis Inc
02 8Ajanta Pharma Limited
03 7Aristo Pharma GmbH
04 2Ascent Pharmaceuticals
05 3Aurolife Pharma LLC
06 1Barr Laboratories
07 4Farbe Firma
08 7Fresenius Kabi USA
09 3GL Pharma
10 4Genus Lifesciences
11 4HAMELN PHARMA PTY. LTD.
12 3Hana Pharm
13 9Hikma Pharmaceuticals
14 7Hospira, Inc.
15 9Janssen-Cilag
16 5Johnson & Johnson Innovative Medicine
17 4Juno Pharmaceuticals Pty Ltd
18 2Lannett Company, Inc.
19 3Link Healthcare
20 15Mallinckrodt Pharmaceuticals
21 7Medsurge Healthcare
22 34Mundipharma
23 3Nesher Pharmaceuticals USA LLC
24 5Osmotica Pharmaceuticals
25 4Padagis
26 6Pharmascience Inc.
27 4Purdue Pharmaceuticals L.P
28 4RHODES PHARMACEUTICALS LP
29 2Rising Pharmaceuticals Inc
30 1The Medicines Patent Pool
01 4CAPSULE, EXTENDED RELEASE;ORAL
02 2Capsule, hard
03 4Extended Release Tablet
04 4Extended-Release Hard Capsule
05 8Extended-Release Tablet
06 2Hard Capsule
07 1Hydromorphone 16Mg 14 Joined' Oral Use Rp
08 1Hydromorphone 32Mg 14 Joined' Oral Use Rp
09 1Hydromorphone 4Mg 14 Joined' Oral Use Rp
10 1Hydromorphone 64Mg 14 Joined' Oral Use Rp
11 1Hydromorphone 8Mg 14 Joined' Oral Use Rp
12 23INJECTABLE;INJECTION
13 2INJECTION
14 1Injectable Solution
15 4Injection
16 4Injection/infusion fluid, resolution
17 1Oral Solution
18 4Pit capsule, hard
19 1Powder
20 1SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
21 4SOLUTION;ORAL
22 1SUPPOSITORY
23 1SYRUP
24 3Solution for Injection
25 5TAB
26 5TABLET
27 21TABLET, EXTENDED RELEASE;ORAL
28 23TABLET;ORAL
29 5Tablet
30 16injection
31 15tablet
32 6Blank
01 7Authorized
02 8Cancelled
03 27DISCN
04 1Deregistered
05 3Dossier Availability- Q2 2017
06 3Generic
07 6Narcotic (CDSA I)
08 5Originator
09 47RX
10 1Specs: USP
11 67Blank
01 9DILAUDID
02 2DILAUDID-HP
03 19Dilaudid
04 2Dilaudid-HP
05 3Dilid
06 4EXALGO
07 5Edunix
08 57HYDROMORPHONE HYDROCHLORIDE
09 2HYDROMORPHONE JUNO
10 2HYDROMORPHONE JUNO-HP
11 2Hidromorfona Aristo
12 3Hikma
13 3Hydromorphone hydrochloride oral solution, US
14 2Hydromorphone-hameln
15 2Hydromorphone-hameln-HP
16 4Jurisdictor
17 5Jurnista
18 1Jurnista 16 Mg
19 2Jurnista 4 Mg
20 2Jurnista 8 Mg
21 2MEDSURGE HYDROMORPHONE 2 mg/1 mL
22 2MEDSURGE HYDROMORPHONE HP 10 mg/1 mL
23 4PALLADONE
24 1PMS HYDROMORPHONE SIROP 1MG/ML
25 1PMS HYDROMORPHONE SUPPOSITOIRE 3MG
26 1PMS-HYDROMORPHONE TAB 1MG
27 1PMS-HYDROMORPHONE TAB 2MG
28 1PMS-HYDROMORPHONE TAB 4MG
29 1PMS-HYDROMORPHONE TAB 8MG
30 10Palladon
31 1Palladon Comp
32 4Palladone Continus
33 15Blank
01 37Australia
02 3Austria
03 6Canada
04 4India
05 5Italy
06 10Norway
07 5South Africa
08 3South Korea
09 15Spain
10 1Sweden
11 10U.S.A
12 76USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : HYDROMORPHONE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/ML
Packaging :
Approval Date : 1995-08-23
Application Number : 74317
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : DILAUDID-HP
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/ML
Packaging :
Approval Date : 1984-01-11
Application Number : 19034
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : DILAUDID-HP
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MG/VIAL
Packaging :
Approval Date : 1994-08-04
Application Number : 19034
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DILAUDID
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 1MG/ML
Packaging :
Approval Date : 2009-04-30
Application Number : 19034
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DILAUDID
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 2MG/ML
Packaging :
Approval Date : 2009-04-30
Application Number : 19034
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DILAUDID
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 4MG/ML
Packaging :
Approval Date : 2009-04-30
Application Number : 19034
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DILAUDID
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 0.2MG/ML
Packaging :
Approval Date : 2020-01-16
Application Number : 19034
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DILAUDID
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 0.5MG/0.5ML
Packaging :
Approval Date : 2017-02-10
Application Number : 19034
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : EXALGO
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2010-03-01
Application Number : 21217
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : EXALGO
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2010-03-01
Application Number : 21217
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : EXALGO
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2010-03-01
Application Number : 21217
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : EXALGO
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2012-08-24
Application Number : 21217
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : PALLADONE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 12MG
Packaging :
Approval Date : 2004-09-24
Application Number : 21044
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : PALLADONE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 16MG
Packaging :
Approval Date : 2004-09-24
Application Number : 21044
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : PALLADONE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 24MG
Packaging :
Approval Date : 2004-09-24
Application Number : 21044
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : PALLADONE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 32MG
Packaging :
Approval Date : 2004-09-24
Application Number : 21044
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DILAUDID
Dosage Form : SOLUTION;ORAL
Dosage Strength : 5MG/5ML
Packaging :
Approval Date : 1992-12-07
Application Number : 19891
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DILAUDID
Dosage Form : TABLET;ORAL
Dosage Strength : 8MG
Packaging :
Approval Date : 1992-12-07
Application Number : 19892
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DILAUDID
Dosage Form : TABLET;ORAL
Dosage Strength : 4MG
Packaging :
Approval Date : 2007-11-09
Application Number : 19892
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DILAUDID
Dosage Form : TABLET;ORAL
Dosage Strength : 2MG
Packaging :
Approval Date : 2007-11-09
Application Number : 19892
Regulatory Info : RX
Registration Country : USA
