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Approved Drug Products containing 204012 listed in the FDA Orange Book. Original Data : FDA Website

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01 HETERO LABS LTD III (2)

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01 CAPSULE, DELAYED REL PELLETS;ORAL (2)

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01 RX (2)

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01 OMEPRAZOLE (2)

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01 No (2)

URL Supplier Web Content
CAPSULE, DELAYED R...
10MG
2019-09-26
204012
OMEPRAZOLE
RX
No
AB
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URL Supplier Web Content
CAPSULE, DELAYED R...
20MG
2019-09-26
204012
OMEPRAZOLE
RX
No
AB
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 204012

Looking for FDA Orange Book APPLICATION 204012 2

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 OMEPRAZOLE, with a corresponding application number 204012.

Regulatory Information RX

With a dosage strength 10MG

Dosage Form Route CAPSULE, DELAYED REL PELLETS; ORAL

Reference Listed Drug No

Approved since 2019-09-26

Therapeutic Equivalence (TE) Code AB

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 OMEPRAZOLE, with a corresponding application number 204012.

Regulatory Information RX

With a dosage strength 20MG

Dosage Form Route CAPSULE, DELAYED REL PELLETS; ORAL

Reference Listed Drug No

Approved since 2019-09-26

Therapeutic Equivalence (TE) Code AB

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