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Approved Drug Products containing 200909 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 TABLET;ORAL (4)

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01 RX (4)

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01 EZETIMIBE AND SIMVASTATIN (4)

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01 No (4)

URL Supplier Web Content
TABLET; ORAL
10MG;40MG
2017-04-26
200909
EZETIMIBE AND SIMV...
RX
No
AB
URL Supplier Web Content
TABLET; ORAL
10MG;10MG
2017-04-26
200909
EZETIMIBE AND SIMV...
RX
No
AB
URL Supplier Web Content
TABLET; ORAL
10MG;80MG
2017-04-26
200909
EZETIMIBE AND SIMV...
RX
No
AB
URL Supplier Web Content
TABLET; ORAL
10MG;20MG
2017-04-26
200909
EZETIMIBE AND SIMV...
RX
No
AB

Looking for FDA Orange Book APPLICATION 200909

Looking for FDA Orange Book APPLICATION 200909 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 EZETIMIBE; SIMVASTATIN, with a corresponding application number 200909.

Regulatory Information RX

With a dosage strength 10MG;40MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2017-04-26

Therapeutic Equivalence (TE) Code AB

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 EZETIMIBE; SIMVASTATIN, with a corresponding application number 200909.

Regulatory Information RX

With a dosage strength 10MG;10MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2017-04-26

Therapeutic Equivalence (TE) Code AB

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 EZETIMIBE; SIMVASTATIN, with a corresponding application number 200909.

Regulatory Information RX

With a dosage strength 10MG;80MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2017-04-26

Therapeutic Equivalence (TE) Code AB

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 EZETIMIBE; SIMVASTATIN, with a corresponding application number 200909.

Regulatory Information RX

With a dosage strength 10MG;20MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2017-04-26

Therapeutic Equivalence (TE) Code AB

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