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Approved Drug Products containing 203354 listed in the FDA Orange Book. Original Data : FDA Website

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01 DR REDDYS (5)

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01 TABLET, EXTENDED RELEASE;ORAL (5)

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01 RX (5)

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01 PRAMIPEXOLE DIHYDROCHLORIDE (5)

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01 No (5)

URL Supplier Web Content
TABLET, EXTENDED R...
4.5MG
2015-08-07
203354
PRAMIPEXOLE DIHYDR...
RX
No
AB
URL Supplier Web Content
TABLET, EXTENDED R...
1.5MG
2015-08-07
203354
PRAMIPEXOLE DIHYDR...
RX
No
AB
URL Supplier Web Content
TABLET, EXTENDED R...
0.375MG
2015-08-07
203354
PRAMIPEXOLE DIHYDR...
RX
No
AB
URL Supplier Web Content
TABLET, EXTENDED R...
3MG
2015-08-07
203354
PRAMIPEXOLE DIHYDR...
RX
No
AB
URL Supplier Web Content
TABLET, EXTENDED R...
0.75MG
2015-08-07
203354
PRAMIPEXOLE DIHYDR...
RX
No
AB

Looking for FDA Orange Book APPLICATION 203354

Looking for FDA Orange Book APPLICATION 203354 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 PRAMIPEXOLE DIHYDROCHLORIDE, with a corresponding application number 203354.

Regulatory Information RX

With a dosage strength 4.5MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2015-08-07

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 PRAMIPEXOLE DIHYDROCHLORIDE, with a corresponding application number 203354.

Regulatory Information RX

With a dosage strength 1.5MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2015-08-07

Therapeutic Equivalence (TE) Code AB

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 PRAMIPEXOLE DIHYDROCHLORIDE, with a corresponding application number 203354.

Regulatory Information RX

With a dosage strength 0.375MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2015-08-07

Therapeutic Equivalence (TE) Code AB

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 PRAMIPEXOLE DIHYDROCHLORIDE, with a corresponding application number 203354.

Regulatory Information RX

With a dosage strength 3MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2015-08-07

Therapeutic Equivalence (TE) Code AB

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 PRAMIPEXOLE DIHYDROCHLORIDE, with a corresponding application number 203354.

Regulatory Information RX

With a dosage strength 0.75MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug No

Approved since 2015-08-07

Therapeutic Equivalence (TE) Code AB

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