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Opana ER
FDF Dossiers

Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

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xyz-pharma-m-2025-06-09

Opana ER

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

10 API Suppliers, 8 USDMF, 3 NDC API, 5 Listed Suppliers

10 API Suppliers
8 USDMF
3 NDC API
5 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

75 FDF Dossiers, 75 FDA Orange Book

75 FDF Dossiers
75 FDA Orange Book

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 1MG/ML, TABLET, EXTENDED RELEASE;ORAL - 10MG, TABLET, EXTENDED RELEASE;ORAL - 15MG, TABLET, EXTENDED RELEASE;ORAL - 20MG, TABLET, EXTENDED RELEASE;ORAL - 30MG, TABLET, EXTENDED RELEASE;ORAL - 40MG, TABLET, EXTENDED RELEASE;ORAL - 5MG, TABLET, EXTENDED RELEASE;ORAL - 7.5MG, TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 1MG/ML
TABLET, EXTENDED RELEASE;ORAL - 10MG
TABLET, EXTENDED RELEASE;ORAL - 15MG
TABLET, EXTENDED RELEASE;ORAL - 20MG
TABLET, EXTENDED RELEASE;ORAL - 30MG
TABLET, EXTENDED RELEASE;ORAL - 40MG
TABLET, EXTENDED RELEASE;ORAL - 5MG
TABLET, EXTENDED RELEASE;ORAL - 7.5MG
TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

DIGITAL CONTENT

15 News #PharmaBuzz

15 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 17 Regulatory FDF Prices

1 US Medicaid Prescriptions
17 Regulatory FDF Prices

PATENTS & EXCLUSIVITIES

42 US Patents

42 US Patents

REF. STANDARDS & IMPURITIES

2 Others

2 Others

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FILTER :

filter Applicant Reset all filters

75 All

01 7Actavis Inc

02 2Ajanta Pharma Limited

03 2Aurolife Pharma LLC

04 2Avanthi Pharma

05 7Endo International

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

filter Dosage Reset all filters

75 All

01 2INJECTABLE;INJECTION

02 1SUPPOSITORY;RECTAL

03 56TABLET, EXTENDED RELEASE;ORAL

04 16TABLET;ORAL

filter Regulatory Info Reset all filters

75 All

01 56DISCN

02 19RX

filter Brand Name Reset all filters

75 All

01 1NUMORPHAN

02 4OPANA

03 14OPANA ER

04 56OXYMORPHONE HYDROCHLORIDE

filter Country Reset all filters

75 All

01 75USA

List of Suppliers

Product Main Page

01

Actavis Inc

IOPC

Not Confirmed

Actavis Inc

IOPC

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : DISCN

Registration Country : USA

OXYMORPHONE HYDROCHLORIDE

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Actavis Inc

IOPC

Not Confirmed

Actavis Inc

IOPC

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : DISCN

Registration Country : USA

OXYMORPHONE HYDROCHLORIDE

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Actavis Inc

IOPC

Not Confirmed

Actavis Inc

IOPC

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : DISCN

Registration Country : USA

OXYMORPHONE HYDROCHLORIDE

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Actavis Inc

IOPC

Not Confirmed

Actavis Inc

IOPC

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : DISCN

Registration Country : USA

OXYMORPHONE HYDROCHLORIDE

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Actavis Inc

IOPC

Not Confirmed

Actavis Inc

IOPC

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : DISCN

Registration Country : USA

OXYMORPHONE HYDROCHLORIDE

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Actavis Inc

IOPC

Not Confirmed

Actavis Inc

IOPC

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : DISCN

Registration Country : USA

OXYMORPHONE HYDROCHLORIDE

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Actavis Inc

IOPC

Not Confirmed

Actavis Inc

IOPC

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : DISCN

Registration Country : USA

OXYMORPHONE HYDROCHLORIDE

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Endo International

IOPC

Not Confirmed

Endo International

IOPC

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : DISCN

Registration Country : USA

OXYMORPHONE HYDROCHLORIDE

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

Digital Content

Corporate PDF

09

Endo International

IOPC

Not Confirmed

Endo International

IOPC

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : DISCN

Registration Country : USA

OXYMORPHONE HYDROCHLORIDE

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

Digital Content

Corporate PDF

10

Endo International

IOPC

Not Confirmed

Endo International

IOPC

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : DISCN

Registration Country : USA

OXYMORPHONE HYDROCHLORIDE

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

Digital Content

Corporate PDF

11

Endo International

IOPC

Not Confirmed

Endo International

IOPC

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : DISCN

Registration Country : USA

OXYMORPHONE HYDROCHLORIDE

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

Digital Content

Corporate PDF

12

Endo International

IOPC

Not Confirmed

Endo International

IOPC

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : DISCN

Registration Country : USA

OXYMORPHONE HYDROCHLORIDE

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

Digital Content

Corporate PDF

13

Endo International

IOPC

Not Confirmed

Endo International

IOPC

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : DISCN

Registration Country : USA

OXYMORPHONE HYDROCHLORIDE

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

Digital Content

Corporate PDF

14

Endo International

IOPC

Not Confirmed

Endo International

IOPC

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : DISCN

Registration Country : USA

OXYMORPHONE HYDROCHLORIDE

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

Digital Content

Corporate PDF

15

Endo Pharm

IOPC

Not Confirmed

Endo Pharm

IOPC

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : DISCN

Registration Country : USA

OXYMORPHONE HYDROCHLORIDE

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

16

Endo Pharm

IOPC

Not Confirmed

Endo Pharm

IOPC

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : DISCN

Registration Country : USA

OXYMORPHONE HYDROCHLORIDE

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

17

Endo Pharm

IOPC

Not Confirmed

Endo Pharm

IOPC

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : DISCN

Registration Country : USA

OXYMORPHONE HYDROCHLORIDE

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

18

Endo Pharm

IOPC

Not Confirmed

Endo Pharm

IOPC

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : DISCN

Registration Country : USA

OXYMORPHONE HYDROCHLORIDE

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

19

Endo Pharm

IOPC

Not Confirmed

Endo Pharm

IOPC

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : DISCN

Registration Country : USA

OXYMORPHONE HYDROCHLORIDE

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

20

Impax Laboratories

IOPC

Not Confirmed

Impax Laboratories

IOPC

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Post an Enquiry

Digital Content

Regulatory Info : RX

Registration Country : USA

OXYMORPHONE HYDROCHLORIDE

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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