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Approved Drug Products containing 209222 listed in the FDA Orange Book. Original Data : FDA Website

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01 ALKEM LABS LTD (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;80MG
2017-12-22
209222
EZETIMIBE AND SIMV...
RX
No
AB
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URL Supplier Web Content
TABLET; ORAL
10MG;20MG
2017-12-22
209222
EZETIMIBE AND SIMV...
RX
No
AB
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
TABLET; ORAL
10MG;40MG
2017-12-22
209222
EZETIMIBE AND SIMV...
RX
No
AB
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
TABLET; ORAL
10MG;10MG
2017-12-22
209222
EZETIMIBE AND SIMV...
RX
No
AB
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 209222

Looking for FDA Orange Book APPLICATION 209222 4

19

Alkem Laboratories, 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 EZETIMIBE; SIMVASTATIN, with a corresponding application number 209222.

Regulatory Information RX

With a dosage strength 10MG;80MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2017-12-22

Therapeutic Equivalence (TE) Code AB

18

Alkem Laboratories, 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 EZETIMIBE; SIMVASTATIN, with a corresponding application number 209222.

Regulatory Information RX

With a dosage strength 10MG;20MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2017-12-22

Therapeutic Equivalence (TE) Code AB

17

Alkem Laboratories, 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 EZETIMIBE; SIMVASTATIN, with a corresponding application number 209222.

Regulatory Information RX

With a dosage strength 10MG;40MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2017-12-22

Therapeutic Equivalence (TE) Code AB

16

Alkem Laboratories, 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 EZETIMIBE; SIMVASTATIN, with a corresponding application number 209222.

Regulatory Information RX

With a dosage strength 10MG;10MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2017-12-22

Therapeutic Equivalence (TE) Code AB

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