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01 22care4

02 2ADAPTIS

03 1ANDA Repository

04 11ANI Pharmaceuticals Inc

05 1Abdi Ibrahim

06 1Acme Lifetech

07 6Actavis Inc

08 2Alfasigma

09 2Amneal Pharmaceuticals

10 4Apotex Inc

11 3Ascent Innovative Medicines

12 2Aspire Lifesciences Pvt Ltd

13 2Biopharm

14 3Chartwell Pharmaceuticals llc

15 2Humanis

16 2IVAX Pharmaceuticals Inc

17 6Ipca Laboratories

18 3Myungmoon Pharm. Co., LTD.

19 4Natco Pharma

20 5Nobel Ilac Sanayii Ve Ticaret A.S.

21 1Nobel Pharma Schweiz Ag

22 2Oxford Pharm

23 2Pangea Biomed

24 1Ravenbhel Pharma

25 1SHREE HARI INTL

26 2Sandoz B2B

27 2Sun Pharmaceutical Industries Limited

28 7Taro Pharmaceutical Industries

29 7Teva Pharmaceutical Industries

30 5Unichem Pharmaceuticals USA, Inc

31 4Viatris

32 7Wyeth Pharmaceuticals Inc

33 2XL Laboratories Private Limited

34 3Zydus Pharmaceuticals

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PharmaCompass

01

Cosmoprof India
Not Confirmed
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Cosmoprof India
Not Confirmed

ETODOLAC

Brand Name : ETODOLAC

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Packaging :

Approval Date : 1997-07-11

Application Number : 74839

Regulatory Info : DISCN

Registration Country : USA

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02

Cosmoprof India
Not Confirmed
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Cosmoprof India
Not Confirmed

ETODOLAC

Brand Name : ETODOLAC

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG

Packaging :

Approval Date : 1997-08-29

Application Number : 74840

Regulatory Info : DISCN

Registration Country : USA

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03

Cosmoprof India
Not Confirmed
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Cosmoprof India
Not Confirmed

ETODOLAC

Brand Name : ETODOLAC

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 1997-08-29

Application Number : 74840

Regulatory Info : DISCN

Registration Country : USA

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04

Cosmoprof India
Not Confirmed
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Cosmoprof India
Not Confirmed

ETODOLAC

Brand Name : ETODOLAC

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG

Packaging :

Approval Date : 1997-12-23

Application Number : 74844

Regulatory Info : DISCN

Registration Country : USA

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05

Cosmoprof India
Not Confirmed
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Cosmoprof India
Not Confirmed

ETODOLAC

Brand Name : ETODOLAC

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 1997-12-23

Application Number : 74844

Regulatory Info : DISCN

Registration Country : USA

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06

Cosmoprof India
Not Confirmed
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Cosmoprof India
Not Confirmed

ETODOLAC

Brand Name : ETODOLAC

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Packaging :

Approval Date : 1997-06-27

Application Number : 74841

Regulatory Info : DISCN

Registration Country : USA

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07

Cosmoprof India
Not Confirmed
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Cosmoprof India
Not Confirmed

ETODOLAC

Brand Name : ETODOLAC

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG

Packaging :

Approval Date : 1997-07-17

Application Number : 74842

Regulatory Info : DISCN

Registration Country : USA

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08

Cosmoprof India
Not Confirmed
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Cosmoprof India
Not Confirmed

ETODOLAC

Brand Name : ETODOLAC

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 1997-07-17

Application Number : 74842

Regulatory Info : DISCN

Registration Country : USA

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09

Cosmoprof India
Not Confirmed
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Cosmoprof India
Not Confirmed

ETODOLAC

Brand Name : ETODOLAC

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Packaging :

Approval Date : 1997-02-28

Application Number : 74819

Regulatory Info : DISCN

Registration Country : USA

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10

Cosmoprof India
Not Confirmed
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Cosmoprof India
Not Confirmed

ETODOLAC

Brand Name : ETODOLAC

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Packaging :

Approval Date : 1998-04-28

Application Number : 74819

Regulatory Info : DISCN

Registration Country : USA

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11

Cosmoprof India
Not Confirmed
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Cosmoprof India
Not Confirmed

ETODOLAC

Brand Name : ETODOLAC

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Packaging :

Approval Date : 1999-04-23

Application Number : 74847

Regulatory Info : DISCN

Registration Country : USA

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12

Cosmoprof India
Not Confirmed
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Cosmoprof India
Not Confirmed

ETODOLAC

Brand Name : ETODOLAC

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Packaging :

Approval Date : 1999-04-23

Application Number : 74847

Regulatory Info : DISCN

Registration Country : USA

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13

Cosmoprof India
Not Confirmed
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Cosmoprof India
Not Confirmed

ETODOLAC

Brand Name : LODINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1991-01-31

Application Number : 18922

Regulatory Info : DISCN

Registration Country : USA

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14

Cosmoprof India
Not Confirmed
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Cosmoprof India
Not Confirmed

ETODOLAC

Brand Name : LODINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 1991-01-31

Application Number : 18922

Regulatory Info : DISCN

Registration Country : USA

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15

Cosmoprof India
Not Confirmed
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Cosmoprof India
Not Confirmed

ETODOLAC

Brand Name : LODINE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1993-07-29

Application Number : 18922

Regulatory Info : DISCN

Registration Country : USA

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16

Cosmoprof India
Not Confirmed
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Cosmoprof India
Not Confirmed

ETODOLAC

Brand Name : LODINE

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1996-06-28

Application Number : 18922

Regulatory Info : DISCN

Registration Country : USA

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17

Cosmoprof India
Not Confirmed
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Cosmoprof India
Not Confirmed

ETODOLAC

Brand Name : LODINE XL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1996-10-25

Application Number : 20584

Regulatory Info : DISCN

Registration Country : USA

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18

Cosmoprof India
Not Confirmed
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Cosmoprof India
Not Confirmed

ETODOLAC

Brand Name : LODINE XL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1996-10-25

Application Number : 20584

Regulatory Info : DISCN

Registration Country : USA

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19

Cosmoprof India
Not Confirmed
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Cosmoprof India
Not Confirmed

ETODOLAC

Brand Name : LODINE XL

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1998-01-20

Application Number : 20584

Regulatory Info : DISCN

Registration Country : USA

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20

SHREE HARI INTL

Country
Cosmoprof India
Not Confirmed
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SHREE HARI INTL

Country
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Cosmoprof India
Not Confirmed

ETODOLAC

Brand Name : ETODOLAC

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Packaging :

Approval Date : 1997-02-28

Application Number : 74846

Regulatory Info : DISCN

Registration Country : USA

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