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

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01 4ABBVIE

02 1ACTAVIS LABS FL

03 1ACTAVIS MID ATLANTIC

04 1ALEMBIC

05 1ALKEM LABS LTD

06 1AMNEAL

07 1AMRING PHARMS

08 1AMTA

09 2ANNORA PHARMA

10 1APIL

11 1AUROBINDO PHARMA LTD

12 1ENCUBE

13 1G AND W LABS INC

14 1MEDA PHARMS

15 3MYLAN

16 2MYLAN SPECIALITY LP

17 1NOVAST LABS

18 1PADAGIS ISRAEL

19 1PHARM SOURCING

20 1SALIX

21 1SANDOZ

22 1SINOTHERAPEUTICS INC

23 2SUN PHARM

24 3TAKEDA PHARMS USA

25 1TEVA PHARMS INC

26 2TEVA PHARMS USA

27 4ZYDUS PHARMS

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PharmaCompass

01

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MESALAMINE

Brand Name : CANASA

Dosage Form : SUPPOSITORY;RECTAL

Dosage Strength : 500MG

Approval Date : 2001-01-05

Application Number : 21252

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Abbvie Company Banner

02

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MESALAMINE

Brand Name : CANASA

Dosage Form : SUPPOSITORY;RECTAL

Dosage Strength : 1GM

Approval Date : 2004-11-05

Application Number : 21252

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Abbvie Company Banner

03

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MESALAMINE

Brand Name : ASACOL HD

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2008-05-29

Application Number : 21830

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie Company Banner

04

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MESALAMINE

Brand Name : DELZICOL

Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

Dosage Strength : 400MG

Approval Date : 2013-02-01

Application Number : 204412

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Abbvie Company Banner

05

APIL

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APIL

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MESALAMINE

Brand Name : ASACOL

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 400MG

Approval Date : 1992-01-31

Application Number : 19651

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

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MESALAMINE

Brand Name : ROWASA

Dosage Form : SUPPOSITORY;RECTAL

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

Approval Date : 1990-12-18

Application Number : 19919

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

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MESALAMINE

Brand Name : PENTASA

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 250MG

Approval Date : 1993-05-10

Application Number : 20049

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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08

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MESALAMINE

Brand Name : PENTASA

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 500MG

Approval Date : 2004-07-08

Application Number : 20049

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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09

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MESALAMINE

Brand Name : ROWASA

Dosage Form : ENEMA;RECTAL

Dosage Strength : 4GM/60ML

Approval Date : 1987-12-24

Application Number : 19618

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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10

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MESALAMINE

Brand Name : SFROWASA

Dosage Form : ENEMA;RECTAL

Dosage Strength : 4GM/60ML

Approval Date : 2008-06-20

Application Number : 19618

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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