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Approved Drug Products containing 21997 listed in the FDA Orange Book. Original Data : FDA Website

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01 MYLAN SPECIALITY LP (2)

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01 TABLET;SUBLINGUAL (2)

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01 RX (2)

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01 EDLUAR (2)

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01 Yes (2)

URL Supplier Web Content
TABLET; SUBLINGUAL
5MG
2009-03-13
21997
EDLUAR
RX
Yes
AB
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URL Supplier Web Content
TABLET; SUBLINGUAL
10MG
2009-03-13
21997
EDLUAR
RX
Yes
AB
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 21997

Looking for FDA Orange Book APPLICATION 21997 2

19

Viatris, 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 ZOLPIDEM TARTRATE, with a corresponding application number 21997.

Regulatory Information RX

With a dosage strength 5MG

Dosage Form Route TABLET; SUBLINGUAL

Reference Listed Drug Yes

Approved since 2009-03-13

Therapeutic Equivalence (TE) Code AB

18

Viatris, 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 ZOLPIDEM TARTRATE, with a corresponding application number 21997.

Regulatory Information RX

With a dosage strength 10MG

Dosage Form Route TABLET; SUBLINGUAL

Reference Listed Drug Yes

Approved since 2009-03-13

Therapeutic Equivalence (TE) Code AB

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