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Approved Drug Products containing 212038 listed in the FDA Orange Book. Original Data : FDA Website

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01 PURDUE PHARMA LP (6)

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01 CAPSULE, EXTENDED RELEASE;ORAL (6)

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01 DISCN (6)

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01 ADHANSIA XR (6)

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01 Yes (6)

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CAPSULE, EXTENDED ...
70MG
2019-02-27
212038
ADHANSIA XR
DISCN
Yes
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CAPSULE, EXTENDED ...
45MG
2019-02-27
212038
ADHANSIA XR
DISCN
Yes
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CAPSULE, EXTENDED ...
25MG
2019-02-27
212038
ADHANSIA XR
DISCN
Yes
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CAPSULE, EXTENDED ...
85MG
2019-02-27
212038
ADHANSIA XR
DISCN
Yes
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CAPSULE, EXTENDED ...
55MG
2019-02-27
212038
ADHANSIA XR
DISCN
Yes
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CAPSULE, EXTENDED ...
35MG
2019-02-27
212038
ADHANSIA XR
DISCN
Yes
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Looking for FDA Orange Book APPLICATION 212038

Looking for FDA Orange Book APPLICATION 212038 6

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 METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 212038.

Regulatory Information DISCN

With a dosage strength 70MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2019-02-27

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 METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 212038.

Regulatory Information DISCN

With a dosage strength 45MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2019-02-27

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 METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 212038.

Regulatory Information DISCN

With a dosage strength 25MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2019-02-27

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 METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 212038.

Regulatory Information DISCN

With a dosage strength 85MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2019-02-27

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 METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 212038.

Regulatory Information DISCN

With a dosage strength 55MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2019-02-27

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 METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 212038.

Regulatory Information DISCN

With a dosage strength 35MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2019-02-27

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