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01 4ANI Pharmaceuticals Inc

02 2Actavis Inc

03 4Alphapharm PTY Ltd

04 1Amneal Pharmaceuticals

05 2Apotex Inc

06 8Arrow Pharmaceuticals

07 1BRAINTREE LABS

08 2Epic Pharma. LLC.

09 1Future Pharma

10 2GSK

11 2Glenmark Pharmaceuticals

12 1Haleon

13 2Hanlim Pharmaceuticals Inc

14 2Medreich

15 2NORVIUM BIOSCIENCE

16 1PENDOPHARM DIVISION OF DE PHARMASCIENCE INC

17 2Pharmascience Inc.

18 2TEOFARMA Srl

19 1Vefa Ilac

20 2Viatris

21 2XYZ Pharma

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PharmaCompass

01

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG

Packaging :

Approval Date : 2002-07-09

Application Number : 75616

Regulatory Info : RX

Registration Country : USA

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02

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 2002-07-09

Application Number : 75616

Regulatory Info : RX

Registration Country : USA

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03

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG

Packaging :

Approval Date : 2002-07-08

Application Number : 75461

Regulatory Info : DISCN

Registration Country : USA

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04

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 2002-07-08

Application Number : 75461

Regulatory Info : DISCN

Registration Country : USA

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05

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG

Packaging :

Approval Date : 2002-09-12

Application Number : 75668

Regulatory Info : DISCN

Registration Country : USA

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06

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 2002-09-12

Application Number : 75668

Regulatory Info : DISCN

Registration Country : USA

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07

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG

Packaging :

Approval Date : 2003-01-23

Application Number : 76383

Regulatory Info : DISCN

Registration Country : USA

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08

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 2003-01-23

Application Number : 76383

Regulatory Info : DISCN

Registration Country : USA

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09

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

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**

Packaging :

Approval Date : 2004-05-25

Application Number : 21494

Regulatory Info : DISCN

Registration Country : USA

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10

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG

Packaging :

Approval Date : 2002-07-05

Application Number : 76178

Regulatory Info : RX

Registration Country : USA

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11

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 2002-07-05

Application Number : 76178

Regulatory Info : RX

Registration Country : USA

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12

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

NIZATIDINE

Brand Name : AXID

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG

Packaging :

Approval Date : 1988-04-12

Application Number : 19508

Regulatory Info : DISCN

Registration Country : USA

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13

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

NIZATIDINE

Brand Name : AXID

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 1988-04-12

Application Number : 19508

Regulatory Info : DISCN

Registration Country : USA

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14

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

NIZATIDINE

Brand Name : AXID AR

Dosage Form : TABLET;ORAL

Dosage Strength : 75MG

Packaging :

Approval Date : 1996-05-09

Application Number : 20555

Regulatory Info : OTC

Registration Country : USA

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15

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG

Packaging :

Approval Date : 2002-07-09

Application Number : 75934

Regulatory Info : DISCN

Registration Country : USA

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16

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 2002-07-09

Application Number : 75934

Regulatory Info : DISCN

Registration Country : USA

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17

XYZ Pharma

AMWC Asia-TDAC
Not Confirmed
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XYZ Pharma

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AMWC Asia-TDAC
Not Confirmed

NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG

Packaging :

Approval Date : 2005-09-15

Application Number : 77314

Regulatory Info : RX

Registration Country : USA

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18

XYZ Pharma

AMWC Asia-TDAC
Not Confirmed
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XYZ Pharma

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AMWC Asia-TDAC
Not Confirmed

NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 2005-09-15

Application Number : 77314

Regulatory Info : RX

Registration Country : USA

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19

NORVIUM BIOSCIENCE

Country
AMWC Asia-TDAC
Not Confirmed
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NORVIUM BIOSCIENCE

Country
arrow
AMWC Asia-TDAC
Not Confirmed

NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG

Packaging :

Approval Date : 2002-07-05

Application Number : 75806

Regulatory Info : DISCN

Registration Country : USA

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20

NORVIUM BIOSCIENCE

Country
AMWC Asia-TDAC
Not Confirmed
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NORVIUM BIOSCIENCE

Country
arrow
AMWC Asia-TDAC
Not Confirmed

NIZATIDINE

Brand Name : NIZATIDINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 2002-07-05

Application Number : 75806

Regulatory Info : DISCN

Registration Country : USA

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