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Approved Drug Products containing 21121 listed in the FDA Orange Book. Original Data : FDA Website

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01 JANSSEN PHARMS (4)

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01 TABLET, EXTENDED RELEASE;ORAL (4)

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01 RX (4)

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01 CONCERTA (4)

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01 Yes (4)

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TABLET, EXTENDED R...
27MG
2002-04-01
21121
CONCERTA
RX
Yes
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TABLET, EXTENDED R...
36MG
2000-08-01
21121
CONCERTA
RX
Yes
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TABLET, EXTENDED R...
54MG
2000-12-08
21121
CONCERTA
RX
Yes
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TABLET, EXTENDED R...
18MG
2000-08-01
21121
CONCERTA
RX
Yes
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Looking for FDA Orange Book APPLICATION 21121

Looking for FDA Orange Book APPLICATION 21121 4

19

Johnson & Johnson Innovative Medicine, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 21121.

Regulatory Information RX

With a dosage strength 27MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2002-04-01

Therapeutic Equivalence (TE) Code AB

18

Johnson & Johnson Innovative Medicine, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 21121.

Regulatory Information RX

With a dosage strength 36MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2000-08-01

Therapeutic Equivalence (TE) Code AB

17

Johnson & Johnson Innovative Medicine, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 21121.

Regulatory Information RX

With a dosage strength 54MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2000-12-08

Therapeutic Equivalence (TE) Code AB

16

Johnson & Johnson Innovative Medicine, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 21121.

Regulatory Information RX

With a dosage strength 18MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2000-08-01

Therapeutic Equivalence (TE) Code AB

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