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Approved Drug Products containing Oxymorphone Hydrochloride listed in the FDA Orange Book. Original Data : FDA Website

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01 ACTAVIS ELIZABETH (7)

02 ASCENT PHARMS INC (2)

03 AUROLIFE PHARMA LLC (2)

04 AVANTHI INC (2)

05 ENDO PHARMS (19)

06 EPIC PHARMA LLC (2)

07 HIKMA (9)

08 IMPAX LABS (7)

09 PAR PHARM (7)

10 SPECGX LLC (9)

11 SUN PHARM INDS LTD (7)

12 TEVA (2)

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01 INJECTABLE;INJECTION (2)

02 SUPPOSITORY;RECTAL (1)

03 TABLET, EXTENDED RELEASE;ORAL (56)

04 TABLET;ORAL (16)

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01 DISCN (56)

02 RX (19)

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01 NUMORPHAN (1)

02 OPANA (4)

03 OPANA ER (14)

04 OXYMORPHONE HYDROCHLORIDE (56)

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01 No (58)

02 Yes (17)

URL Supplier Web Content
INJECTABLE;INJECTION
1.5MG/ML
1982-01-01
11707
OPANA
DISCN
No
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INJECTABLE;INJECTION
1MG/ML
1982-01-01
11707
OPANA
DISCN
Yes
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SUPPOSITORY;RECTAL
5MG
1982-01-01
11738
NUMORPHAN
DISCN
No
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TABLET, EXTENDED RELEASE;ORAL
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2006-06-22
21610
OPANA ER
DISCN
Yes
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TABLET, EXTENDED RELEASE;ORAL
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2006-06-22
21610
OPANA ER
DISCN
Yes
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TABLET, EXTENDED RELEASE;ORAL
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2006-06-22
21610
OPANA ER
DISCN
Yes
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TABLET, EXTENDED RELEASE;ORAL
40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2006-06-22
21610
OPANA ER
DISCN
Yes
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TABLET, EXTENDED RELEASE;ORAL
7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2008-02-29
21610
OPANA ER
DISCN
Yes
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TABLET, EXTENDED RELEASE;ORAL
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2008-02-29
21610
OPANA ER
DISCN
Yes
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TABLET, EXTENDED RELEASE;ORAL
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2008-02-29
21610
OPANA ER
DISCN
Yes
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