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Approved Drug Products containing 91313 listed in the FDA Orange Book. Original Data : FDA Website

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01 DR REDDYS LABS SA (5)

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01 TABLET;ORAL (5)

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01 DISCN (5)

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01 OXYCODONE HYDROCHLORIDE (5)

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01 No (5)

URL Supplier Web Content
TABLET; ORAL
20MG
2016-04-29
91313
OXYCODONE HYDROCHL...
DISCN
No
URL Supplier Web Content
TABLET; ORAL
30MG
2011-02-18
91313
OXYCODONE HYDROCHL...
DISCN
No
URL Supplier Web Content
TABLET; ORAL
5MG
2011-02-18
91313
OXYCODONE HYDROCHL...
DISCN
No
URL Supplier Web Content
TABLET; ORAL
10MG
2016-04-29
91313
OXYCODONE HYDROCHL...
DISCN
No
URL Supplier Web Content
TABLET; ORAL
15MG
2011-02-18
91313
OXYCODONE HYDROCHL...
DISCN
No

Looking for FDA Orange Book APPLICATION 91313

Looking for FDA Orange Book APPLICATION 91313 5

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 OXYCODONE HYDROCHLORIDE, with a corresponding application number 91313.

Regulatory Information DISCN

With a dosage strength 20MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2016-04-29

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 OXYCODONE HYDROCHLORIDE, with a corresponding application number 91313.

Regulatory Information DISCN

With a dosage strength 30MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2011-02-18

17

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 OXYCODONE HYDROCHLORIDE, with a corresponding application number 91313.

Regulatory Information DISCN

With a dosage strength 5MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2011-02-18

16

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 OXYCODONE HYDROCHLORIDE, with a corresponding application number 91313.

Regulatory Information DISCN

With a dosage strength 10MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2016-04-29

15

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 OXYCODONE HYDROCHLORIDE, with a corresponding application number 91313.

Regulatory Information DISCN

With a dosage strength 15MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2011-02-18

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