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Approved Drug Products containing 78050 listed in the FDA Orange Book. Original Data : FDA Website

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01 SANDOZ (2)

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01 TABLET, ORALLY DISINTEGRATING;ORAL (2)

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01 RX (2)

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01 ONDANSETRON (2)

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01 No (2)

URL Supplier Web Content
TABLET, ORALLY DIS...
4MG
2007-08-13
78050
ONDANSETRON
RX
No
AB
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URL Supplier Web Content
TABLET, ORALLY DIS...
8MG
2007-08-13
78050
ONDANSETRON
RX
No
AB
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PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 78050

Looking for FDA Orange Book APPLICATION 78050 2

19

Sandoz B2B, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for A global leader in antibiotics.

One of their notable products is ONDANSETRON, with a corresponding application number 78050.

Regulatory Information RX

With a dosage strength 4MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug No

Approved since 2007-08-13

Therapeutic Equivalence (TE) Code AB

18

Sandoz B2B, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for A global leader in antibiotics.

One of their notable products is ONDANSETRON, with a corresponding application number 78050.

Regulatory Information RX

With a dosage strength 8MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug No

Approved since 2007-08-13

Therapeutic Equivalence (TE) Code AB

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