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Approved Drug Products containing 21086 listed in the FDA Orange Book. Original Data : FDA Website

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01 CHEPLAPHARM (4)

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01 TABLET, ORALLY DISINTEGRATING;ORAL (4)

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01 RX (4)

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01 ZYPREXA ZYDIS (4)

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01 Yes (4)

URL Supplier Web Content
TABLET, ORALLY DIS...
15MG
2000-04-06
21086
ZYPREXA ZYDIS
RX
Yes
AB
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TABLET, ORALLY DIS...
5MG
2000-04-06
21086
ZYPREXA ZYDIS
RX
Yes
AB
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URL Supplier Web Content
TABLET, ORALLY DIS...
20MG
2000-04-06
21086
ZYPREXA ZYDIS
RX
Yes
AB
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PHARMACOMPASS
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URL Supplier Web Content
TABLET, ORALLY DIS...
10MG
2000-04-06
21086
ZYPREXA ZYDIS
RX
Yes
AB
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Looking for FDA Orange Book APPLICATION 21086

Looking for FDA Orange Book APPLICATION 21086 4

19

Cheplapharm Arzneimittel Gmbh, based in Germany, is a pharmaceutical company.

One of their notable products is OLANZAPINE, with a corresponding application number 21086.

Regulatory Information RX

With a dosage strength 15MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug Yes

Approved since 2000-04-06

Therapeutic Equivalence (TE) Code AB

18

Cheplapharm Arzneimittel Gmbh, based in Germany, is a pharmaceutical company.

One of their notable products is OLANZAPINE, with a corresponding application number 21086.

Regulatory Information RX

With a dosage strength 5MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug Yes

Approved since 2000-04-06

Therapeutic Equivalence (TE) Code AB

17

Cheplapharm Arzneimittel Gmbh, based in Germany, is a pharmaceutical company.

One of their notable products is OLANZAPINE, with a corresponding application number 21086.

Regulatory Information RX

With a dosage strength 20MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug Yes

Approved since 2000-04-06

Therapeutic Equivalence (TE) Code AB

16

Cheplapharm Arzneimittel Gmbh, based in Germany, is a pharmaceutical company.

One of their notable products is OLANZAPINE, with a corresponding application number 21086.

Regulatory Information RX

With a dosage strength 10MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING; ORAL

Reference Listed Drug Yes

Approved since 2000-04-06

Therapeutic Equivalence (TE) Code AB

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