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Approved Drug Products containing 208644 listed in the FDA Orange Book. Original Data : FDA Website

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01 ALKEM LABS LTD (1)

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01 TABLET, DELAYED RELEASE;ORAL (1)

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01 RX (1)

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01 RABEPRAZOLE SODIUM (1)

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01 No (1)

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TABLET, DELAYED RE...
20MG
2018-04-24
208644
RABEPRAZOLE SODIUM
RX
No
AB
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Looking for FDA Orange Book APPLICATION 208644

Looking for FDA Orange Book APPLICATION 208644 1

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 RABEPRAZOLE SODIUM, with a corresponding application number 208644.

Regulatory Information RX

With a dosage strength 20MG

Dosage Form Route TABLET, DELAYED RELEASE; ORAL

Reference Listed Drug No

Approved since 2018-04-24

Therapeutic Equivalence (TE) Code AB

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