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Approved Drug Products containing 207313 listed in the FDA Orange Book. Original Data : FDA Website

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01 DR REDDYS LABS SA (1)

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01 CAPSULE;ORAL (1)

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01 RX (1)

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01 BUTALBITAL AND ACETAMINOPHEN (1)

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01 No (1)

URL Supplier Web Content
CAPSULE; ORAL
300MG;50MG
2017-12-27
207313
BUTALBITAL AND ACE...
RX
No
AA

Looking for FDA Orange Book APPLICATION 207313

Looking for FDA Orange Book APPLICATION 207313 1

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 ACETAMINOPHEN; BUTALBITAL, with a corresponding application number 207313.

Regulatory Information RX

With a dosage strength 300MG;50MG

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug No

Approved since 2017-12-27

Therapeutic Equivalence (TE) Code AA

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