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Approved Drug Products containing 78279 listed in the FDA Orange Book. Original Data : FDA Website

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01 DR REDDYS (2)

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01 CAPSULE, DELAYED REL PELLETS;ORAL (2)

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01 RX (2)

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01 ESOMEPRAZOLE MAGNESIUM (2)

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01 No (2)

URL Supplier Web Content
CAPSULE, DELAYED R...
EQ 40MG BASE
2015-09-25
78279
ESOMEPRAZOLE MAGNE...
RX
No
AB
URL Supplier Web Content
CAPSULE, DELAYED R...
EQ 20MG BASE
2015-09-25
78279
ESOMEPRAZOLE MAGNE...
RX
No
AB

Looking for FDA Orange Book APPLICATION 78279

Looking for FDA Orange Book APPLICATION 78279 2

19

Dr. Reddy\'s Laboratories, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

One of their notable products is ESOMEPRAZOLE MAGNESIUM, with a corresponding application number 78279.

Regulatory Information RX

With a dosage strength EQ 40MG BASE

Dosage Form Route CAPSULE, DELAYED REL PELLETS; ORAL

Reference Listed Drug No

Approved since 2015-09-25

Therapeutic Equivalence (TE) Code AB

18

Dr. Reddy\'s Laboratories, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

One of their notable products is ESOMEPRAZOLE MAGNESIUM, with a corresponding application number 78279.

Regulatory Information RX

With a dosage strength EQ 20MG BASE

Dosage Form Route CAPSULE, DELAYED REL PELLETS; ORAL

Reference Listed Drug No

Approved since 2015-09-25

Therapeutic Equivalence (TE) Code AB

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