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Approved Drug Products containing 20973 listed in the FDA Orange Book. Original Data : FDA Website

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01 WOODWARD (2)

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01 TABLET, DELAYED RELEASE;ORAL (2)

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01 DISCN (1)

02 RX (1)

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01 ACIPHEX (2)

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01 Yes (2)

URL Supplier Web Content
TABLET, DELAYED RE...
10MG **Federal Reg...
2002-05-29
20973
ACIPHEX
DISCN
Yes
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URL Supplier Web Content
TABLET, DELAYED RE...
20MG
1999-08-19
20973
ACIPHEX
RX
Yes
AB
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Looking for FDA Orange Book APPLICATION 20973

Looking for FDA Orange Book APPLICATION 20973 2

19

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

One of their notable products is RABEPRAZOLE SODIUM, with a corresponding application number 20973.

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With a dosage strength 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Reference Listed Drug Yes

Approved since 2002-05-29

18

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

One of their notable products is RABEPRAZOLE SODIUM, with a corresponding application number 20973.

Regulatory Information RX

With a dosage strength 20MG

Dosage Form Route TABLET, DELAYED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 1999-08-19

Therapeutic Equivalence (TE) Code AB

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