01 1ALEMBIC
02 1ALKEM LABS LTD
03 3AMNEAL
04 3APOTEX
05 3APOTEX INC
06 3AUROBINDO PHARMA LTD
07 2BAYER HLTHCARE
08 1BIONPHARMA
09 2EPIC PHARMA LLC
10 1GLAND PHARMA LTD
11 2HIKMA
12 2MEDA PHARMS
13 3MYLAN SPECIALITY LP
14 2NORVIUM BIOSCIENCE
15 3PADAGIS ISRAEL
16 1SANDOZ
17 1SCIEGEN PHARMS INC
18 1SOMERSET THERAPS LLC
19 2SUN PHARM
20 1UPSHER SMITH LABS
21 1ZYDUS PHARMS
01 8SOLUTION/DROPS;OPHTHALMIC
02 30SPRAY, METERED;NASAL
03 1SPRAY;NASAL
01 13DISCN
02 5OTC
03 18RX
04 3Blank
01 1ASTELIN
02 4ASTEPRO
03 1ASTEPRO ALLERGY
04 26AZELASTINE HYDROCHLORIDE
05 1AZELASTINE HYDROCHLORIDE ALLERGY
06 2AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
07 1AZELASTINE HYDROCHLORIDE CHILDRENS ALLERGY
08 1CHILDRENS ASTEPRO ALLERGY
09 1DYMISTA
10 1OPTIVAR
01 30No
02 6Yes
03 3Blank
RLD : No
TE Code : AB
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
RLD : No
TE Code : AT
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
RLD : No
TE Code : AB
Brand Name : AZELASTINE HYDROCHLORIDE
Dosage Form : SPRAY, METERED;NASAL
Dosage Strength : 0.137MG/SPRAY
Approval Date : 2015-07-28
Application Number : 90176
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD :
TE Code :
Brand Name : ASTEPRO
Dosage Form : SPRAY, METERED;NASAL
Dosage Strength : 0.1%
Approval Date :
Application Number : 22371
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : ASTEPRO
Dosage Form : SPRAY, METERED;NASAL
Dosage Strength : 0.15%
Approval Date :
Application Number : 22371
RX/OTC/DISCN :
RLD :
TE Code :
RLD : No
TE Code : AT
Brand Name : AZELASTINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.05%
Approval Date : 2010-06-21
Application Number : 78738
RX/OTC/DISCN : RX
RLD : No
TE Code : AT
RLD : Yes
TE Code :
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Dosage Strength : 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 :
RLD : No
TE Code :
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 :
RLD : Yes
TE Code :
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 :
Portfolio PDF
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RLD : Yes
TE Code :
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 :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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