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Approved Drug Products containing 78490 listed in the FDA Orange Book. Original Data : FDA Website

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01 DR REDDYS LABS LTD (3)

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01 CAPSULE, DELAYED REL PELLETS;ORAL (3)

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01 RX (3)

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01 OMEPRAZOLE (3)

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01 No (3)

URL Supplier Web Content
CAPSULE, DELAYED R...
20MG
2009-03-16
78490
OMEPRAZOLE
RX
No
AB
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URL Supplier Web Content
CAPSULE, DELAYED R...
40MG
2009-04-17
78490
OMEPRAZOLE
RX
No
AB
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URL Supplier Web Content
CAPSULE, DELAYED R...
10MG
2009-03-16
78490
OMEPRAZOLE
RX
No
AB
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US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 78490

Looking for FDA Orange Book APPLICATION 78490 3

19

XYZ Pharma, based in Gabon, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is OMEPRAZOLE, with a corresponding application number 78490.

Regulatory Information RX

With a dosage strength 20MG

Dosage Form Route CAPSULE, DELAYED REL PELLETS; ORAL

Reference Listed Drug No

Approved since 2009-03-16

Therapeutic Equivalence (TE) Code AB

18

XYZ Pharma, based in Gabon, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is OMEPRAZOLE, with a corresponding application number 78490.

Regulatory Information RX

With a dosage strength 40MG

Dosage Form Route CAPSULE, DELAYED REL PELLETS; ORAL

Reference Listed Drug No

Approved since 2009-04-17

Therapeutic Equivalence (TE) Code AB

17

XYZ Pharma, based in Gabon, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is OMEPRAZOLE, with a corresponding application number 78490.

Regulatory Information RX

With a dosage strength 10MG

Dosage Form Route CAPSULE, DELAYED REL PELLETS; ORAL

Reference Listed Drug No

Approved since 2009-03-16

Therapeutic Equivalence (TE) Code AB

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