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Approved Drug Products containing 202880 listed in the FDA Orange Book. Original Data : FDA Website

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01 RECRO GAINESVILLE (6)

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01 CAPSULE, EXTENDED RELEASE;ORAL (6)

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01 DISCN (6)

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01 ZOHYDRO ER (6)

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01 Yes (6)

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CAPSULE, EXTENDED ...
30MG
2013-10-25
202880
ZOHYDRO ER
DISCN
Yes
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CAPSULE, EXTENDED ...
15MG
2013-10-25
202880
ZOHYDRO ER
DISCN
Yes
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CAPSULE, EXTENDED ...
40MG
2013-10-25
202880
ZOHYDRO ER
DISCN
Yes
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CAPSULE, EXTENDED ...
20MG
2013-10-25
202880
ZOHYDRO ER
DISCN
Yes
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CAPSULE, EXTENDED ...
10MG
2013-10-25
202880
ZOHYDRO ER
DISCN
Yes
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CAPSULE, EXTENDED ...
50MG
2013-10-25
202880
ZOHYDRO ER
DISCN
Yes
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Looking for FDA Orange Book APPLICATION 202880

Looking for FDA Orange Book APPLICATION 202880 6

19

Societal CDMO, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Experts in Development and Manufacturing Solutions for Oral Solid Dosage Forms

One of their notable products is HYDROCODONE BITARTRATE, with a corresponding application number 202880.

Regulatory Information DISCN

With a dosage strength 30MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2013-10-25

18

Societal CDMO, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Experts in Development and Manufacturing Solutions for Oral Solid Dosage Forms

One of their notable products is HYDROCODONE BITARTRATE, with a corresponding application number 202880.

Regulatory Information DISCN

With a dosage strength 15MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2013-10-25

17

Societal CDMO, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Experts in Development and Manufacturing Solutions for Oral Solid Dosage Forms

One of their notable products is HYDROCODONE BITARTRATE, with a corresponding application number 202880.

Regulatory Information DISCN

With a dosage strength 40MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2013-10-25

16

Societal CDMO, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Experts in Development and Manufacturing Solutions for Oral Solid Dosage Forms

One of their notable products is HYDROCODONE BITARTRATE, with a corresponding application number 202880.

Regulatory Information DISCN

With a dosage strength 20MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2013-10-25

15

Societal CDMO, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Experts in Development and Manufacturing Solutions for Oral Solid Dosage Forms

One of their notable products is HYDROCODONE BITARTRATE, with a corresponding application number 202880.

Regulatory Information DISCN

With a dosage strength 10MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2013-10-25

14

Societal CDMO, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Experts in Development and Manufacturing Solutions for Oral Solid Dosage Forms

One of their notable products is HYDROCODONE BITARTRATE, with a corresponding application number 202880.

Regulatory Information DISCN

With a dosage strength 50MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2013-10-25

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