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Approved Drug Products containing 21774 listed in the FDA Orange Book. Original Data : FDA Website

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01 SANOFI AVENTIS US (2)

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01 TABLET, EXTENDED RELEASE;ORAL (2)

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01 RX (2)

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01 AMBIEN CR (2)

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01 Yes (2)

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TABLET, EXTENDED R...
12.5MG
2005-09-02
21774
AMBIEN CR
RX
Yes
AB
Sanofi Company Banner

Cophex 2024

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
TABLET, EXTENDED R...
6.25MG
2005-09-02
21774
AMBIEN CR
RX
Yes
AB
Sanofi Company Banner

Cophex 2024

Not Confirmed

envelop Contact Supplier

Looking for FDA Orange Book APPLICATION 21774

Looking for FDA Orange Book APPLICATION 21774 2

19

Sanofi, based in France, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

They are recognized for Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

One of their notable products is ZOLPIDEM TARTRATE, with a corresponding application number 21774.

Regulatory Information RX

With a dosage strength 12.5MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2005-09-02

Therapeutic Equivalence (TE) Code AB

18

Sanofi, based in France, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

They are recognized for Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

One of their notable products is ZOLPIDEM TARTRATE, with a corresponding application number 21774.

Regulatory Information RX

With a dosage strength 6.25MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2005-09-02

Therapeutic Equivalence (TE) Code AB

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