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Approved Drug Products containing 209501 listed in the FDA Orange Book. Original Data : FDA Website

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01 UPJOHN (3)

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01 TABLET, EXTENDED RELEASE;ORAL (3)

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01 RX (3)

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01 LYRICA CR (3)

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01 Yes (3)

URL Supplier Web Content
TABLET, EXTENDED R...
330MG
2017-10-11
209501
LYRICA CR
RX
Yes
AB
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URL Supplier Web Content
TABLET, EXTENDED R...
82.5MG
2017-10-11
209501
LYRICA CR
RX
Yes
AB
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TABLET, EXTENDED R...
165MG
2017-10-11
209501
LYRICA CR
RX
Yes
AB
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Looking for FDA Orange Book APPLICATION 209501

Looking for FDA Orange Book APPLICATION 209501 3

19

Pfizer Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is PREGABALIN, with a corresponding application number 209501.

Regulatory Information RX

With a dosage strength 330MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2017-10-11

Therapeutic Equivalence (TE) Code AB

18

Pfizer Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is PREGABALIN, with a corresponding application number 209501.

Regulatory Information RX

With a dosage strength 82.5MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2017-10-11

Therapeutic Equivalence (TE) Code AB

17

Pfizer Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is PREGABALIN, with a corresponding application number 209501.

Regulatory Information RX

With a dosage strength 165MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2017-10-11

Therapeutic Equivalence (TE) Code AB

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