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Approved Drug Products containing 77524 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 CREAM;TOPICAL (1)

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01 RX (1)

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01 FLUOROURACIL (1)

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01 No (1)

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CREAM; TOPICAL
5%
2008-04-11
77524
FLUOROURACIL
RX
No
AB

Looking for FDA Orange Book APPLICATION 77524

Looking for FDA Orange Book APPLICATION 77524 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 FLUOROURACIL, with a corresponding application number 77524.

Regulatory Information RX

With a dosage strength 5%

Dosage Form Route CREAM; TOPICAL

Reference Listed Drug No

Approved since 2008-04-11

Therapeutic Equivalence (TE) Code AB

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