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Approved Drug Products containing 209311 listed in the FDA Orange Book. Original Data : FDA Website

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01 IRONSHORE PHARMS (5)

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01 CAPSULE, EXTENDED RELEASE;ORAL (5)

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01 RX (5)

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01 JORNAY PM (5)

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01 Yes (5)

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CAPSULE, EXTENDED ...
100MG
2018-08-08
209311
JORNAY PM
RX
Yes
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CAPSULE, EXTENDED ...
60MG
2018-08-08
209311
JORNAY PM
RX
Yes
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CAPSULE, EXTENDED ...
20MG
2018-08-08
209311
JORNAY PM
RX
Yes
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CAPSULE, EXTENDED ...
80MG
2018-08-08
209311
JORNAY PM
RX
Yes
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CAPSULE, EXTENDED ...
40MG
2018-08-08
209311
JORNAY PM
RX
Yes
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Looking for FDA Orange Book APPLICATION 209311

Looking for FDA Orange Book APPLICATION 209311 5

19

Ironshore Pharmaceuticals, based in U.S.A, is a pharmaceutical company.

One of their notable products is METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 209311.

Regulatory Information RX

With a dosage strength 100MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2018-08-08

18

Ironshore Pharmaceuticals, based in U.S.A, is a pharmaceutical company.

One of their notable products is METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 209311.

Regulatory Information RX

With a dosage strength 60MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2018-08-08

17

Ironshore Pharmaceuticals, based in U.S.A, is a pharmaceutical company.

One of their notable products is METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 209311.

Regulatory Information RX

With a dosage strength 20MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2018-08-08

16

Ironshore Pharmaceuticals, based in U.S.A, is a pharmaceutical company.

One of their notable products is METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 209311.

Regulatory Information RX

With a dosage strength 80MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2018-08-08

15

Ironshore Pharmaceuticals, based in U.S.A, is a pharmaceutical company.

One of their notable products is METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 209311.

Regulatory Information RX

With a dosage strength 40MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2018-08-08

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