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01 2BAYER HLTHCARE

02 1ALEMBIC

03 1ALKEM LABS LTD

04 3AMNEAL

05 4APOTEX

06 2APOTEX INC

07 1AUROBINDO PHARMA

08 2AUROBINDO PHARMA LTD

09 1BIONPHARMA

10 2EPIC PHARMA LLC

11 1GLAND

12 2HIKMA

13 2MEDA PHARMS

14 1MYLAN SPECIALITY LP

15 3PADAGIS ISRAEL

16 1PADAGIS US

17 2RISING

18 1SANDOZ

19 1SCIEGEN PHARMS

20 1SOMERSET THERAPS LLC

21 2SUN PHARM

22 1TEVA PHARMS USA INC

23 2VIATRIS

24 1ZYDUS PHARMS

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PharmaCompass

03

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

AZELASTINE HYDROCHLORIDE

Brand Name : AZELASTINE HYDROCHLORIDE

Dosage Form : SPRAY, METERED;NASAL

Dosage Strength : 0.137MG/SPRAY

Approval Date : 2009-04-30

Application Number : 77954

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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04

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

AZELASTINE HYDROCHLORIDE

Brand Name : AZELASTINE HYDROCHLORIDE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.05%

Approval Date : 2009-08-03

Application Number : 78621

RX/OTC/DISCN : RX

RLD : No

TE Code : AT

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05

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

AZELASTINE HYDROCHRLORIDE

Brand Name : ASTEPRO

Dosage Form : SPRAY, METERED;NASAL

Dosage Strength : 0.1%

Approval Date :

Application Number : 22371

RX/OTC/DISCN :

RLD :

TE Code :

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06

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

AZELASTINE HYDROCHRLORIDE

Brand Name : ASTEPRO

Dosage Form : SPRAY, METERED;NASAL

Dosage Strength : 0.15%

Approval Date :

Application Number : 22371

RX/OTC/DISCN :

RLD :

TE Code :

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07

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

AZELASTINE HYDROCHLORIDE

Brand Name : ASTELIN

Dosage Form : SPRAY, METERED;NASAL

Dosage Strength : 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1996-11-01

Application Number : 20114

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

AZELASTINE HYDROCHLORIDE

Brand Name : OPTIVAR

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2000-05-22

Application Number : 21127

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

AZELASTINE HYDROCHLORIDE

Brand Name : ASTEPRO

Dosage Form : SPRAY, METERED;NASAL

Dosage Strength : 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2008-10-15

Application Number : 22203

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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10

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

AZELASTINE HYDROCHLORIDE

Brand Name : ASTEPRO

Dosage Form : SPRAY, METERED;NASAL

Dosage Strength : 0.2055MG/SPRAY

Approval Date : 2009-08-31

Application Number : 22203

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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