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Approved Drug Products containing 210354 listed in the FDA Orange Book. Original Data : FDA Website

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01 ASCENT PHARMS INC (3)

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01 TABLET, CHEWABLE;ORAL (3)

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01 RX (3)

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01 METHYLPHENIDATE HYDROCHLORIDE (3)

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01 No (3)

URL Supplier Web Content
TABLET, CHEWABLE; ...
5MG
2017-12-29
210354
METHYLPHENIDATE HY...
RX
No
AB
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URL Supplier Web Content
TABLET, CHEWABLE; ...
10MG
2017-12-29
210354
METHYLPHENIDATE HY...
RX
No
AB
ASK
US
PHARMACOMPASS
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your Marketing & Sales content
URL Supplier Web Content
TABLET, CHEWABLE; ...
2.5MG
2017-12-29
210354
METHYLPHENIDATE HY...
RX
No
AB
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 210354

Looking for FDA Orange Book APPLICATION 210354 3

19

Ajanta Pharma Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 210354.

Regulatory Information RX

With a dosage strength 5MG

Dosage Form Route TABLET, CHEWABLE; ORAL

Reference Listed Drug No

Approved since 2017-12-29

Therapeutic Equivalence (TE) Code AB

18

Ajanta Pharma Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 210354.

Regulatory Information RX

With a dosage strength 10MG

Dosage Form Route TABLET, CHEWABLE; ORAL

Reference Listed Drug No

Approved since 2017-12-29

Therapeutic Equivalence (TE) Code AB

17

Ajanta Pharma Limited, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 210354.

Regulatory Information RX

With a dosage strength 2.5MG

Dosage Form Route TABLET, CHEWABLE; ORAL

Reference Listed Drug No

Approved since 2017-12-29

Therapeutic Equivalence (TE) Code AB

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