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Approved Drug Products containing 210519 listed in the FDA Orange Book. Original Data : FDA Website

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01 ALKEM LABS LTD (3)

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01 TABLET, FOR SUSPENSION;ORAL (3)

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01 RX (3)

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01 DEFERASIROX (3)

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01 No (3)

URL Supplier Web Content
TABLET, FOR SUSPEN...
125MG
2019-11-20
210519
DEFERASIROX
RX
No
AB
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URL Supplier Web Content
TABLET, FOR SUSPEN...
250MG
2019-11-20
210519
DEFERASIROX
RX
No
AB
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
TABLET, FOR SUSPEN...
500MG
2019-11-20
210519
DEFERASIROX
RX
No
AB
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 210519

Looking for FDA Orange Book APPLICATION 210519 3

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 DEFERASIROX, with a corresponding application number 210519.

Regulatory Information RX

With a dosage strength 125MG

Dosage Form Route TABLET, FOR SUSPENSION; ORAL

Reference Listed Drug No

Approved since 2019-11-20

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 DEFERASIROX, with a corresponding application number 210519.

Regulatory Information RX

With a dosage strength 250MG

Dosage Form Route TABLET, FOR SUSPENSION; ORAL

Reference Listed Drug No

Approved since 2019-11-20

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 DEFERASIROX, with a corresponding application number 210519.

Regulatory Information RX

With a dosage strength 500MG

Dosage Form Route TABLET, FOR SUSPENSION; ORAL

Reference Listed Drug No

Approved since 2019-11-20

Therapeutic Equivalence (TE) Code AB

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