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

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01 5TARO

02 2TARO PHARM INDS

03 1ACTAVIS ELIZABETH

04 2AMNEAL PHARMS CO

05 11ANI PHARMS

06 2APOTEX

07 2APOTEX INC

08 5BAYSHORE PHARMS LLC

09 2BIOPHARM

10 3CHARTWELL MOLECULES

11 2EDENBRIDGE PHARMS

12 4IPCA LABS LTD

13 2IVAX SUB TEVA PHARMS

14 4MYLAN

15 4NATCO PHARMA

16 2OXFORD PHARMS

17 2PANGEA

18 2RANBAXY LABS LTD

19 2SANDOZ

20 2SHREE HARI INTL

21 7TEVA

22 3WATSON LABS

23 2WATSON LABS FLORIDA

24 7WYETH PHARMS INC

25 3ZYDUS PHARMS

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PharmaCompass

01

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Not Confirmed

ETODOLAC

Brand Name : ETODOLAC

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Approval Date : 1998-03-11

Application Number : 75074

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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02

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Not Confirmed

ETODOLAC

Brand Name : ETODOLAC

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 2000-04-25

Application Number : 75074

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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03

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Not Confirmed

ETODOLAC

Brand Name : ETODOLAC

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG

Approval Date : 1998-04-30

Application Number : 75078

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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04

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Not Confirmed

ETODOLAC

Brand Name : ETODOLAC

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Approval Date : 1998-04-30

Application Number : 75078

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

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Not Confirmed

ETODOLAC

Brand Name : ETODOLAC

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 400MG

Approval Date : 2003-03-13

Application Number : 76174

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

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Not Confirmed

ETODOLAC

Brand Name : ETODOLAC

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 500MG

Approval Date : 2003-03-13

Application Number : 76174

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

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Not Confirmed

ETODOLAC

Brand Name : ETODOLAC

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 600MG

Approval Date : 2003-03-13

Application Number : 76174

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

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Not Confirmed
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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**

Approval Date : 1991-01-31

Application Number : 18922

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

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Not Confirmed
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Not Confirmed

ETODOLAC

Brand Name : LODINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG

Approval Date : 1991-01-31

Application Number : 18922

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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10

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Not Confirmed
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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**

Approval Date : 1993-07-29

Application Number : 18922

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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