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Approved Drug Products containing 206627 listed in the FDA Orange Book. Original Data : FDA Website

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01 PURDUE PHARMA LP (7)

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01 TABLET, EXTENDED RELEASE;ORAL (7)

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01 RX (7)

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01 HYSINGLA ER (7)

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01 Yes (7)

URL Supplier Web Content
TABLET, EXTENDED R...
100MG
2014-11-20
206627
HYSINGLA ER
RX
Yes
AB
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TABLET, EXTENDED R...
60MG
2014-11-20
206627
HYSINGLA ER
RX
Yes
AB
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TABLET, EXTENDED R...
30MG
2014-11-20
206627
HYSINGLA ER
RX
Yes
AB
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TABLET, EXTENDED R...
120MG
2014-11-20
206627
HYSINGLA ER
RX
Yes
AB
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TABLET, EXTENDED R...
80MG
2014-11-20
206627
HYSINGLA ER
RX
Yes
AB
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TABLET, EXTENDED R...
40MG
2014-11-20
206627
HYSINGLA ER
RX
Yes
AB
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PHARMACOMPASS
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TABLET, EXTENDED R...
20MG
2014-11-20
206627
HYSINGLA ER
RX
Yes
AB
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Looking for FDA Orange Book APPLICATION 206627

Looking for FDA Orange Book APPLICATION 206627 7

19

Purdue Pharmaceuticals L.P, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is HYDROCODONE BITARTRATE, with a corresponding application number 206627.

Regulatory Information RX

With a dosage strength 100MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2014-11-20

Therapeutic Equivalence (TE) Code AB

18

Purdue Pharmaceuticals L.P, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is HYDROCODONE BITARTRATE, with a corresponding application number 206627.

Regulatory Information RX

With a dosage strength 60MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2014-11-20

Therapeutic Equivalence (TE) Code AB

17

Purdue Pharmaceuticals L.P, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is HYDROCODONE BITARTRATE, with a corresponding application number 206627.

Regulatory Information RX

With a dosage strength 30MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2014-11-20

Therapeutic Equivalence (TE) Code AB

16

Purdue Pharmaceuticals L.P, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is HYDROCODONE BITARTRATE, with a corresponding application number 206627.

Regulatory Information RX

With a dosage strength 120MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2014-11-20

Therapeutic Equivalence (TE) Code AB

15

Purdue Pharmaceuticals L.P, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is HYDROCODONE BITARTRATE, with a corresponding application number 206627.

Regulatory Information RX

With a dosage strength 80MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2014-11-20

Therapeutic Equivalence (TE) Code AB

14

Purdue Pharmaceuticals L.P, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is HYDROCODONE BITARTRATE, with a corresponding application number 206627.

Regulatory Information RX

With a dosage strength 40MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2014-11-20

Therapeutic Equivalence (TE) Code AB

13

Purdue Pharmaceuticals L.P, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is HYDROCODONE BITARTRATE, with a corresponding application number 206627.

Regulatory Information RX

With a dosage strength 20MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2014-11-20

Therapeutic Equivalence (TE) Code AB

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