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Approved Drug Products containing 76137 listed in the FDA Orange Book. Original Data : FDA Website

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01 DR REDDYS LABS SA (3)

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01 CAPSULE, EXTENDED RELEASE;ORAL (3)

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01 DISCN (3)

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01 DEXTROAMPHETAMINE SULFATE (3)

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01 No (3)

URL Supplier Web Content
CAPSULE, EXTENDED ...
10MG
2002-01-18
76137
DEXTROAMPHETAMINE ...
DISCN
No
URL Supplier Web Content
CAPSULE, EXTENDED ...
15MG
2002-01-18
76137
DEXTROAMPHETAMINE ...
DISCN
No
URL Supplier Web Content
CAPSULE, EXTENDED ...
5MG
2002-01-18
76137
DEXTROAMPHETAMINE ...
DISCN
No

Looking for FDA Orange Book APPLICATION 76137

Looking for FDA Orange Book APPLICATION 76137 3

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 DEXTROAMPHETAMINE SULFATE, with a corresponding application number 76137.

Regulatory Information DISCN

With a dosage strength 10MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2002-01-18

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 DEXTROAMPHETAMINE SULFATE, with a corresponding application number 76137.

Regulatory Information DISCN

With a dosage strength 15MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2002-01-18

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 DEXTROAMPHETAMINE SULFATE, with a corresponding application number 76137.

Regulatory Information DISCN

With a dosage strength 5MG

Dosage Form Route CAPSULE, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2002-01-18

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