01 5Actavis Inc
02 8Ajanta Pharma Limited
03 4Apotex Inc
04 2Ascent Pharmaceuticals
05 3Aurolife Pharma LLC
06 1Barr Laboratories
07 4Farbe Firma
08 2Fresenius Kabi Austria
09 7Fresenius Kabi USA
10 3GL Pharma
11 4Genus Lifesciences
12 4HAMELN PHARMA PTY. LTD.
13 3Hana Pharm
14 9Hikma Pharmaceuticals
15 7Hospira, Inc.
16 1JAMP PHARMA
17 5Janssen-Cilag
18 5Johnson & Johnson Innovative Medicine
19 4Juno Pharmaceuticals Pty Ltd
20 2Lannett Company, Inc.
21 3Link Healthcare
22 15Mallinckrodt Pharmaceuticals
23 10Medsurge Healthcare
24 49Mundipharma
25 3Nesher Pharmaceuticals USA LLC
26 1Nostrum Laboratories
27 5Osmotica Pharmaceuticals
28 4Padagis
29 1Pfizer Inc
30 11Pharmascience Inc.
31 12Purdue Pharma
32 4Purdue Pharmaceuticals L.P
33 4RHODES PHARMACEUTICALS LP
34 2Rising Pharmaceuticals Inc
35 4STERIMAX INC
36 5Sandoz B2B
37 2Sterinova Inc.
38 1Streuli Pharma
01 8CAPSULE (SUSTAINED-RELEASE)
02 4CAPSULE, EXTENDED RELEASE;ORAL
03 2Capsule, hard
04 4Extended Release Tablet
05 2HARD CAPSULES
06 1Hydromorphone 16Mg 14 Joined' Oral Use Rp
07 1Hydromorphone 32Mg 14 Joined' Oral Use Rp
08 1Hydromorphone 4Mg 14 Joined' Oral Use Rp
09 1Hydromorphone 64Mg 14 Joined' Oral Use Rp
10 1Hydromorphone 8Mg 14 Joined' Oral Use Rp
11 23INJECTABLE;INJECTION
12 2INJECTION
13 4INJECTION / INFUSION
14 4Injection
15 4Injection/infusion fluid, resolution
16 2Kaps
17 4PROLONGED-RELEASE CAPSULE, HARD
18 4Pit capsule, hard
19 1Powder
20 8Ret Kaps
21 15SOLUTION
22 1SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
23 4SOLUTION;ORAL
24 1SUPPOSITORY
25 2SYRUP
26 3Solution for Injection
27 5TAB
28 17TABLET
29 21TABLET, EXTENDED RELEASE;ORAL
30 23TABLET;ORAL
31 5Tablet
32 1Tropfen
33 16injection
34 15tablet
35 9Blank
01 27DISCN
02 3Dossier Availability- Q2 2017
03 3Generic
04 42Narcotic (CDSA I)
05 5Originator
06 47RX
07 1Specs: USP
08 91Blank
01 4APO-HYDROMORPHONE
02 13DILAUDID
03 2DILAUDID-HP
04 19Dilaudid
05 2Dilaudid-HP
06 3Dilid
07 4EXALGO
08 2HYDROMORPH CONTIN
09 1HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 12MG
10 1HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 18MG
11 1HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 24MG
12 1HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 30MG
13 1HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 3MG
14 1HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 6MG
15 1HYDROMORPHONE HP 10
16 1HYDROMORPHONE HP 20
17 1HYDROMORPHONE HP 50
18 57HYDROMORPHONE HYDROCHLORIDE
19 1HYDROMORPHONE HYDROCHLORIDE INJECTION
20 1HYDROMORPHONE HYDROCHLORIDE INJECTION HP 10
21 1HYDROMORPHONE HYDROCHLORIDE INJECTION HP 50
22 1HYDROMORPHONE HYDROCHLORIDE INJECTION HP FORTE
23 6HYDROMORPHONE HYDROCHLORIDE INJECTION USP
24 2HYDROMORPHONE HYDROCHLORIDE INJECTION, USP
25 2HYDROMORPHONE JUNO
26 2HYDROMORPHONE JUNO-HP
27 3Hikma
28 3Hydromorphone hydrochloride oral solution, US
29 2Hydromorphone-hameln
30 2Hydromorphone-hameln-HP
31 1Hydromorphoni HCl Streuli
32 5Jurnista
33 1Jurnista 16 Mg
34 2Jurnista 4 Mg
35 2Jurnista 8 Mg
36 2MEDSURGE HYDROMORPHONE 2 mg/1 mL
37 2MEDSURGE HYDROMORPHONE HP 10 mg/1 mL
38 4PALLADONE
39 2PMS HYDROMORPHONE SIROP 1MG/ML
40 1PMS HYDROMORPHONE SUPPOSITOIRE 3MG
41 2PMS-HYDROMORPHONE TAB 1MG
42 2PMS-HYDROMORPHONE TAB 2MG
43 2PMS-HYDROMORPHONE TAB 4MG
44 2PMS-HYDROMORPHONE TAB 8MG
45 30Palladon
46 3pms-HYDROmorphone
47 15Blank
01 40Australia
02 3Austria
03 42Canada
04 4India
05 5Italy
06 10Norway
07 5South Africa
08 3South Korea
09 10Sweden
10 11Switzerland
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 : HYDROMORPHONE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/ML
Packaging :
Approval Date : 2003-04-25
Application Number : 76444
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 : HYDROMORPHONE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 8MG
Packaging :
Approval Date : 1998-07-29
Application Number : 74597
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : HYDROMORPHONE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 4MG
Packaging :
Approval Date : 2009-05-29
Application Number : 74597
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : HYDROMORPHONE HYDROCHLORIDE
Dosage Form : SOLUTION;ORAL
Dosage Strength : 5MG/5ML
Packaging :
Approval Date : 1998-07-29
Application Number : 74653
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : HYDROMORPHONE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/ML
Packaging :
Approval Date : 1997-06-19
Application Number : 74598
Regulatory Info : DISCN
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 : RX
Registration Country : USA
Brand Name : HYDROMORPHONE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 8MG
Packaging :
Approval Date : 2004-12-23
Application Number : 76855
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : HYDROMORPHONE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 2MG
Packaging :
Approval Date : 2007-09-19
Application Number : 76855
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : HYDROMORPHONE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 4MG
Packaging :
Approval Date : 2007-09-19
Application Number : 76855
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : HYDROMORPHONE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 2MG
Packaging :
Approval Date : 2005-11-09
Application Number : 77311
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : HYDROMORPHONE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 8MG
Packaging :
Approval Date : 2005-10-18
Application Number : 76723
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
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