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Approved Drug Products containing 78458 listed in the FDA Orange Book. Original Data : FDA Website

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01 DR REDDYS LABS SA (4)

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01 CAPSULE, EXTENDED RELEASE;ORAL (4)

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01 RX (4)

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01 METHYLPHENIDATE HYDROCHLORIDE (4)

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01 No (4)

URL Supplier Web Content
CAPSULE, EXTENDED ...
30MG
2011-12-01
78458
METHYLPHENIDATE HY...
RX
No
AB1
URL Supplier Web Content
CAPSULE, EXTENDED ...
40MG
2011-12-01
78458
METHYLPHENIDATE HY...
RX
No
AB1
URL Supplier Web Content
CAPSULE, EXTENDED ...
20MG
2011-12-01
78458
METHYLPHENIDATE HY...
RX
No
AB1
URL Supplier Web Content
CAPSULE, EXTENDED ...
60MG
2016-06-23
78458
METHYLPHENIDATE HY...
RX
No
AB1

Looking for FDA Orange Book APPLICATION 78458

Looking for FDA Orange Book APPLICATION 78458 4

19

Dr. Reddy\'s Laboratories, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

One of their notable products is METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 78458.

Regulatory Information RX

With a dosage strength 30MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2011-12-01

Therapeutic Equivalence (TE) Code AB1

18

Dr. Reddy\'s Laboratories, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

One of their notable products is METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 78458.

Regulatory Information RX

With a dosage strength 40MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2011-12-01

Therapeutic Equivalence (TE) Code AB1

17

Dr. Reddy\'s Laboratories, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

One of their notable products is METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 78458.

Regulatory Information RX

With a dosage strength 20MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2011-12-01

Therapeutic Equivalence (TE) Code AB1

16

Dr. Reddy\'s Laboratories, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

One of their notable products is METHYLPHENIDATE HYDROCHLORIDE, with a corresponding application number 78458.

Regulatory Information RX

With a dosage strength 60MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2016-06-23

Therapeutic Equivalence (TE) Code AB1

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