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Approved Drug Products containing 22362 listed in the FDA Orange Book. Original Data : FDA Website

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01 COSETTE (2)

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01 FOR SUSPENSION;ORAL (2)

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01 DISCN (1)

02 RX (1)

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01 WELCHOL (2)

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01 Yes (2)

URL Supplier Web Content
FOR SUSPENSION; OR...
3.75GM/PACKET
2009-10-02
22362
WELCHOL
RX
Yes
AB
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URL Supplier Web Content
FOR SUSPENSION; OR...
1.875GM/PACKET **F...
2009-10-02
22362
WELCHOL
DISCN
Yes
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Looking for FDA Orange Book APPLICATION 22362

Looking for FDA Orange Book APPLICATION 22362 2

19

Cosette Pharma, based in U.S.A, is a pharmaceutical company.

One of their notable products is COLESEVELAM HYDROCHLORIDE, with a corresponding application number 22362.

Regulatory Information RX

With a dosage strength 3.75GM/PACKET

Dosage Form Route FOR SUSPENSION; ORAL

Reference Listed Drug Yes

Approved since 2009-10-02

Therapeutic Equivalence (TE) Code AB

18

Cosette Pharma, based in U.S.A, is a pharmaceutical company.

One of their notable products is COLESEVELAM HYDROCHLORIDE, with a corresponding application number 22362.

Regulatory Information DISCN

With a dosage strength 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route FOR SUSPENSION; ORAL

Reference Listed Drug Yes

Approved since 2009-10-02

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