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Approved Drug Products containing 78834 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 TABLET;ORAL (1)

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01 RX (1)

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01 LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (1)

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01 No (1)

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TABLET; ORAL
0.03MG,0.01MG;0.15...
2011-05-31
78834
LEVONORGESTREL AND...
RX
No
AB

Looking for FDA Orange Book APPLICATION 78834

Looking for FDA Orange Book APPLICATION 78834 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 ETHINYL ESTRADIOL; LEVONORGESTREL, with a corresponding application number 78834.

Regulatory Information RX

With a dosage strength 0.03MG,0.01MG;0.15MG,N/A

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2011-05-31

Therapeutic Equivalence (TE) Code AB

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