01 7Actavis Inc
02 2Ajanta Pharma Limited
03 2Aurolife Pharma LLC
04 2Avanthi Pharma
05 7ENDO OPERATIONS
06 12Endo Pharm
07 2Epic Pharma. LLC.
08 9Hikma Pharmaceuticals
09 7Impax Laboratories
10 9Mallinckrodt Pharmaceuticals
11 7Par Pharmaceutical
12 7Sun Pharmaceutical Industries Limited
13 2Teva Pharmaceutical Industries
01 2INJECTABLE;INJECTION
02 1SUPPOSITORY;RECTAL
03 56TABLET, EXTENDED RELEASE;ORAL
04 16TABLET;ORAL
01 56DISCN
02 19RX
01 1NUMORPHAN
02 4OPANA
03 14OPANA ER
04 56OXYMORPHONE HYDROCHLORIDE
01 75USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OXYMORPHONE HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 7.5MG
Packaging :
Approval Date : 2010-12-13
Application Number : 79046
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OXYMORPHONE HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 15MG
Packaging :
Approval Date : 2010-12-13
Application Number : 79046
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OXYMORPHONE HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2013-07-11
Application Number : 79046
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OXYMORPHONE HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2013-07-11
Application Number : 79046
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OXYMORPHONE HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 20MG
Packaging :
Approval Date : 2013-07-11
Application Number : 79046
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OXYMORPHONE HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 30MG
Packaging :
Approval Date : 2013-07-11
Application Number : 79046
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OXYMORPHONE HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 40MG
Packaging :
Approval Date : 2013-07-11
Application Number : 79046
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OPANA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 1.5MG/ML
Packaging :
Approval Date : 1982-01-01
Application Number : 11707
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OPANA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 1MG/ML
Packaging :
Approval Date : 1982-01-01
Application Number : 11707
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : NUMORPHAN
Dosage Form : SUPPOSITORY;RECTAL
Dosage Strength : 5MG
Packaging :
Approval Date : 1982-01-01
Application Number : 11738
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OPANA
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2006-06-22
Application Number : 21611
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OPANA
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2006-06-22
Application Number : 21611
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : OXYMORPHONE HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2010-06-14
Application Number : 79087
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OPANA ER
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2006-06-22
Application Number : 21610
Regulatory Info : DISCN
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OPANA ER
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2006-06-22
Application Number : 21610
Regulatory Info : DISCN
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OPANA ER
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2006-06-22
Application Number : 21610
Regulatory Info : DISCN
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OPANA ER
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2006-06-22
Application Number : 21610
Regulatory Info : DISCN
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OPANA ER
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2008-02-29
Application Number : 21610
Regulatory Info : DISCN
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OPANA ER
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2008-02-29
Application Number : 21610
Regulatory Info : DISCN
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OPANA ER
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2008-02-29
Application Number : 21610
Regulatory Info : DISCN
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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