01 7ACTAVIS ELIZABETH
02 2ASCENT PHARMS INC
03 2AUROLIFE PHARMA LLC
04 2AVANTHI INC
05 7ENDO OPERATIONS
06 12ENDO PHARMS
07 2EPIC PHARMA LLC
08 9HIKMA
09 7IMPAX LABS
10 7PAR PHARM
11 9SPECGX LLC
12 7SUN PHARM INDS LTD
13 2TEVA
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 58No
02 17Yes
RLD : No
TE Code :
Brand Name : OPANA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 1.5MG/ML
Approval Date : 1982-01-01
Application Number : 11707
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : OPANA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 1MG/ML
Approval Date : 1982-01-01
Application Number : 11707
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : NUMORPHAN
Dosage Form : SUPPOSITORY;RECTAL
Dosage Strength : 5MG
Approval Date : 1982-01-01
Application Number : 11738
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
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Dosage Strength : 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2006-06-22
Application Number : 21610
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
RLD : Yes
TE Code :
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Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2006-06-22
Application Number : 21610
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
RLD : Yes
TE Code :
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Dosage Strength : 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2006-06-22
Application Number : 21610
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
RLD : Yes
TE Code :
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Dosage Strength : 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2006-06-22
Application Number : 21610
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
RLD : Yes
TE Code :
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**
Approval Date : 2008-02-29
Application Number : 21610
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
RLD : Yes
TE Code :
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**
Approval Date : 2008-02-29
Application Number : 21610
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
RLD : Yes
TE Code :
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**
Approval Date : 2008-02-29
Application Number : 21610
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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