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Approved Drug Products containing 77691 listed in the FDA Orange Book. Original Data : FDA Website

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01 AUROBINDO PHARMA (5)

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01 TABLET;ORAL (5)

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01 RX (5)

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01 SIMVASTATIN (5)

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01 No (5)

URL Supplier Web Content
TABLET; ORAL
40MG
2006-12-20
77691
SIMVASTATIN
RX
No
AB
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URL Supplier Web Content
TABLET; ORAL
10MG
2006-12-20
77691
SIMVASTATIN
RX
No
AB
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URL Supplier Web Content
TABLET; ORAL
80MG
2006-12-20
77691
SIMVASTATIN
RX
No
AB
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URL Supplier Web Content
TABLET; ORAL
20MG
2006-12-20
77691
SIMVASTATIN
RX
No
AB
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URL Supplier Web Content
TABLET; ORAL
5MG
2006-12-20
77691
SIMVASTATIN
RX
No
AB
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PHARMACOMPASS
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Looking for FDA Orange Book APPLICATION 77691

Looking for FDA Orange Book APPLICATION 77691 5

19

Aurobindo 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 SIMVASTATIN, with a corresponding application number 77691.

Regulatory Information RX

With a dosage strength 40MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2006-12-20

Therapeutic Equivalence (TE) Code AB

18

Aurobindo 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 SIMVASTATIN, with a corresponding application number 77691.

Regulatory Information RX

With a dosage strength 10MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2006-12-20

Therapeutic Equivalence (TE) Code AB

17

Aurobindo 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 SIMVASTATIN, with a corresponding application number 77691.

Regulatory Information RX

With a dosage strength 80MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2006-12-20

Therapeutic Equivalence (TE) Code AB

16

Aurobindo 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 SIMVASTATIN, with a corresponding application number 77691.

Regulatory Information RX

With a dosage strength 20MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2006-12-20

Therapeutic Equivalence (TE) Code AB

15

Aurobindo 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 SIMVASTATIN, with a corresponding application number 77691.

Regulatory Information RX

With a dosage strength 5MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2006-12-20

Therapeutic Equivalence (TE) Code AB

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