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Approved Drug Products containing 200533 listed in the FDA Orange Book. Original Data : FDA Website

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01 COLLEGIUM PHARM INC (5)

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01 TABLET, EXTENDED RELEASE;ORAL (5)

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01 RX (5)

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01 NUCYNTA ER (5)

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01 Yes (5)

URL Supplier Web Content
TABLET, EXTENDED R...
EQ 150MG BASE
2011-08-25
200533
NUCYNTA ER
RX
Yes
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TABLET, EXTENDED R...
EQ 50MG BASE
2011-08-25
200533
NUCYNTA ER
RX
Yes
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TABLET, EXTENDED R...
EQ 200MG BASE
2011-08-25
200533
NUCYNTA ER
RX
Yes
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TABLET, EXTENDED R...
EQ 100MG BASE
2011-08-25
200533
NUCYNTA ER
RX
Yes
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TABLET, EXTENDED R...
EQ 250MG BASE
2011-08-25
200533
NUCYNTA ER
RX
Yes
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Looking for FDA Orange Book APPLICATION 200533

Looking for FDA Orange Book APPLICATION 200533 5

19

Collegium Pharmaceutical, based in U.S.A, is a pharmaceutical company.

One of their notable products is TAPENTADOL HYDROCHLORIDE, with a corresponding application number 200533.

Regulatory Information RX

With a dosage strength EQ 150MG BASE

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2011-08-25

18

Collegium Pharmaceutical, based in U.S.A, is a pharmaceutical company.

One of their notable products is TAPENTADOL HYDROCHLORIDE, with a corresponding application number 200533.

Regulatory Information RX

With a dosage strength EQ 50MG BASE

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2011-08-25

17

Collegium Pharmaceutical, based in U.S.A, is a pharmaceutical company.

One of their notable products is TAPENTADOL HYDROCHLORIDE, with a corresponding application number 200533.

Regulatory Information RX

With a dosage strength EQ 200MG BASE

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2011-08-25

16

Collegium Pharmaceutical, based in U.S.A, is a pharmaceutical company.

One of their notable products is TAPENTADOL HYDROCHLORIDE, with a corresponding application number 200533.

Regulatory Information RX

With a dosage strength EQ 100MG BASE

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2011-08-25

15

Collegium Pharmaceutical, based in U.S.A, is a pharmaceutical company.

One of their notable products is TAPENTADOL HYDROCHLORIDE, with a corresponding application number 200533.

Regulatory Information RX

With a dosage strength EQ 250MG BASE

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2011-08-25

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