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Approved Drug Products containing Prestwick2_000921 listed in the FDA Orange Book. Original Data : FDA Website

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01 1AMNEAL PHARMS

02 4ANI PHARMS

03 2APOTEX INC

04 1BRAINTREE

05 2DR REDDYS LABS LTD

06 2EPIC PHARMA LLC

07 2GLENMARK PHARMS INC

08 1HALEON US HOLDINGS

09 2MYLAN PHARMS INC

10 2NORVIUM BIOSCIENCE

11 2SMITHKLINE BEECHAM

12 2WATSON LABS

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PharmaCompass

01

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NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG

Approval Date : 2002-07-09

Application Number : 75616

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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02

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NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Approval Date : 2002-07-09

Application Number : 75616

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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03

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NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG

Approval Date : 2002-07-08

Application Number : 75461

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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04

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NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Approval Date : 2002-07-08

Application Number : 75461

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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05

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NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG

Approval Date : 2002-09-12

Application Number : 75668

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

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NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Approval Date : 2002-09-12

Application Number : 75668

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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07

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NIZATIDINE

Brand Name : AXID

Dosage Form : SOLUTION;ORAL

Dosage Strength : 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2004-05-25

Application Number : 21494

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

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NIZATIDINE

Brand Name : AXID

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG

Approval Date : 1988-04-12

Application Number : 19508

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

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NIZATIDINE

Brand Name : AXID

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Approval Date : 1988-04-12

Application Number : 19508

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

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NIZATIDINE

Brand Name : AXID AR

Dosage Form : TABLET;ORAL

Dosage Strength : 75MG

Approval Date : 1996-05-09

Application Number : 20555

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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