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Approved Drug Products containing 208658 listed in the FDA Orange Book. Original Data : FDA Website

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01 BOEHRINGER INGELHEIM (4)

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01 TABLET, EXTENDED RELEASE;ORAL (4)

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01 RX (4)

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01 SYNJARDY XR (4)

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01 Yes (4)

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TABLET, EXTENDED R...
25MG;1GM
2016-12-09
208658
SYNJARDY XR
RX
Yes
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TABLET, EXTENDED R...
10MG;1GM
2016-12-09
208658
SYNJARDY XR
RX
Yes
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TABLET, EXTENDED R...
12.5MG;1GM
2016-12-09
208658
SYNJARDY XR
RX
Yes
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TABLET, EXTENDED R...
5MG;1GM
2016-12-09
208658
SYNJARDY XR
RX
Yes
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Looking for FDA Orange Book APPLICATION 208658

Looking for FDA Orange Book APPLICATION 208658 4

19

Boehringer Ingelheim GmbH, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE, with a corresponding application number 208658.

Regulatory Information RX

With a dosage strength 25MG;1GM

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2016-12-09

18

Boehringer Ingelheim GmbH, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE, with a corresponding application number 208658.

Regulatory Information RX

With a dosage strength 10MG;1GM

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2016-12-09

17

Boehringer Ingelheim GmbH, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE, with a corresponding application number 208658.

Regulatory Information RX

With a dosage strength 12.5MG;1GM

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2016-12-09

16

Boehringer Ingelheim GmbH, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE, with a corresponding application number 208658.

Regulatory Information RX

With a dosage strength 5MG;1GM

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2016-12-09

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