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Approved Drug Products containing 209908 listed in the FDA Orange Book. Original Data : FDA Website

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01 HETERO LABS LTD III (4)

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01 TABLET;ORAL (4)

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01 RX (4)

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01 TADALAFIL (4)

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01 No (4)

URL Supplier Web Content
TABLET; ORAL
10MG
2019-03-26
209908
TADALAFIL
RX
No
AB1
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URL Supplier Web Content
TABLET; ORAL
2.5MG
2019-03-26
209908
TADALAFIL
RX
No
AB1
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URL Supplier Web Content
TABLET; ORAL
20MG
2019-03-26
209908
TADALAFIL
RX
No
AB1
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PHARMACOMPASS
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URL Supplier Web Content
TABLET; ORAL
5MG
2019-03-26
209908
TADALAFIL
RX
No
AB1
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 209908

Looking for FDA Orange Book APPLICATION 209908 4

19

Hetero Drugs, 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 TADALAFIL, with a corresponding application number 209908.

Regulatory Information RX

With a dosage strength 10MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2019-03-26

Therapeutic Equivalence (TE) Code AB1

18

Hetero Drugs, 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 TADALAFIL, with a corresponding application number 209908.

Regulatory Information RX

With a dosage strength 2.5MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2019-03-26

Therapeutic Equivalence (TE) Code AB1

17

Hetero Drugs, 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 TADALAFIL, with a corresponding application number 209908.

Regulatory Information RX

With a dosage strength 20MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2019-03-26

Therapeutic Equivalence (TE) Code AB1

16

Hetero Drugs, 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 TADALAFIL, with a corresponding application number 209908.

Regulatory Information RX

With a dosage strength 5MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2019-03-26

Therapeutic Equivalence (TE) Code AB1

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