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Approved Drug Products containing 209637 listed in the FDA Orange Book. Original Data : FDA Website

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01 NOVO (4)

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01 SOLUTION;SUBCUTANEOUS (4)

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01 RX (4)

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01 OZEMPIC (4)

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01 Yes (4)

URL Supplier Web Content
SOLUTION; SUBCUTAN...
2MG/3ML (0.68MG/ML...
2022-10-06
209637
OZEMPIC
RX
Yes
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SOLUTION; SUBCUTAN...
4MG/3ML (1.34MG/ML...
2019-04-09
209637
OZEMPIC
RX
Yes
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SOLUTION; SUBCUTAN...
8MG/3ML (2.68MG/ML...
2022-03-28
209637
OZEMPIC
RX
Yes
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SOLUTION; SUBCUTAN...
2MG/1.5ML (1.34MG/...
2017-12-05
209637
OZEMPIC
RX
Yes
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Looking for FDA Orange Book APPLICATION 209637

Looking for FDA Orange Book APPLICATION 209637 4

19

Novo Nordisk, based in Denmark, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is SEMAGLUTIDE, with a corresponding application number 209637.

Regulatory Information RX

With a dosage strength 2MG/3ML (0.68MG/ML)

Dosage Form Route SOLUTION; SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2022-10-06

18

Novo Nordisk, based in Denmark, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is SEMAGLUTIDE, with a corresponding application number 209637.

Regulatory Information RX

With a dosage strength 4MG/3ML (1.34MG/ML)

Dosage Form Route SOLUTION; SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2019-04-09

17

Novo Nordisk, based in Denmark, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is SEMAGLUTIDE, with a corresponding application number 209637.

Regulatory Information RX

With a dosage strength 8MG/3ML (2.68MG/ML)

Dosage Form Route SOLUTION; SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2022-03-28

16

Novo Nordisk, based in Denmark, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is SEMAGLUTIDE, with a corresponding application number 209637.

Regulatory Information RX

With a dosage strength 2MG/1.5ML (1.34MG/ML)

Dosage Form Route SOLUTION; SUBCUTANEOUS

Reference Listed Drug Yes

Approved since 2017-12-05

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