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Approved Drug Products containing 201655 listed in the FDA Orange Book. Original Data : FDA Website

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01 ENDO PHARMS (7)

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01 TABLET, EXTENDED RELEASE;ORAL (7)

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01 DISCN (7)

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01 OPANA ER (7)

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01 Yes (7)

URL Supplier Web Content
TABLET, EXTENDED R...
40MG
2011-12-09
201655
OPANA ER
DISCN
Yes
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TABLET, EXTENDED R...
20MG
2011-12-09
201655
OPANA ER
DISCN
Yes
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TABLET, EXTENDED R...
10MG
2011-12-09
201655
OPANA ER
DISCN
Yes
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TABLET, EXTENDED R...
5MG
2011-12-09
201655
OPANA ER
DISCN
Yes
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TABLET, EXTENDED R...
30MG
2011-12-09
201655
OPANA ER
DISCN
Yes
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TABLET, EXTENDED R...
15MG
2011-12-09
201655
OPANA ER
DISCN
Yes
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TABLET, EXTENDED R...
7.5MG
2011-12-09
201655
OPANA ER
DISCN
Yes
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Looking for FDA Orange Book APPLICATION 201655

Looking for FDA Orange Book APPLICATION 201655 7

19

Endo Pharm, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is OXYMORPHONE HYDROCHLORIDE, with a corresponding application number 201655.

Regulatory Information DISCN

With a dosage strength 40MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2011-12-09

18

Endo Pharm, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is OXYMORPHONE HYDROCHLORIDE, with a corresponding application number 201655.

Regulatory Information DISCN

With a dosage strength 20MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2011-12-09

17

Endo Pharm, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is OXYMORPHONE HYDROCHLORIDE, with a corresponding application number 201655.

Regulatory Information DISCN

With a dosage strength 10MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2011-12-09

16

Endo Pharm, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is OXYMORPHONE HYDROCHLORIDE, with a corresponding application number 201655.

Regulatory Information DISCN

With a dosage strength 5MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2011-12-09

15

Endo Pharm, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is OXYMORPHONE HYDROCHLORIDE, with a corresponding application number 201655.

Regulatory Information DISCN

With a dosage strength 30MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2011-12-09

14

Endo Pharm, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is OXYMORPHONE HYDROCHLORIDE, with a corresponding application number 201655.

Regulatory Information DISCN

With a dosage strength 15MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2011-12-09

13

Endo Pharm, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is OXYMORPHONE HYDROCHLORIDE, with a corresponding application number 201655.

Regulatory Information DISCN

With a dosage strength 7.5MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2011-12-09

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