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Approved Drug Products containing 20801 listed in the FDA Orange Book. Original Data : FDA Website

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01 J AND J CONSUMER INC (2)

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01 TABLET, CHEWABLE;ORAL (2)

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01 DISCN (1)

02 OTC (1)

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01 PEPCID AC (2)

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01 Yes (2)

URL Supplier Web Content
TABLET, CHEWABLE; ...
20MG
2007-12-17
20801
PEPCID AC
OTC
Yes
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URL Supplier Web Content
TABLET, CHEWABLE; ...
10MG **Federal Reg...
1998-09-24
20801
PEPCID AC
DISCN
Yes
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Looking for FDA Orange Book APPLICATION 20801

Looking for FDA Orange Book APPLICATION 20801 2

19

Johnson & Johnson, 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 FAMOTIDINE, with a corresponding application number 20801.

Regulatory Information OTC

With a dosage strength 20MG

Dosage Form Route TABLET, CHEWABLE; ORAL

Reference Listed Drug Yes

Approved since 2007-12-17

18

Johnson & Johnson, 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 FAMOTIDINE, with a corresponding application number 20801.

Regulatory Information DISCN

With a dosage strength 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET, CHEWABLE; ORAL

Reference Listed Drug Yes

Approved since 1998-09-24

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