01 1ALEMBIC
02 1ALKEM LABS LTD
03 3AMNEAL
04 3APOTEX
05 3APOTEX INC
06 1AUROBINDO PHARMA
07 2AUROBINDO PHARMA LTD
08 2BAYER HLTHCARE
09 1BIONPHARMA
10 2EPIC PHARMA LLC
11 1GLAND PHARMA LTD
12 2HIKMA
13 2MEDA PHARMS
14 1MYLAN SPECIALITY LP
15 4NORVIUM BIOSCIENCE
16 3PADAGIS ISRAEL
17 1SANDOZ
18 1SCIEGEN PHARMS INC
19 1SOMERSET THERAPS LLC
20 2SUN PHARM
21 1UPSHER SMITH LABS
22 1ZYDUS PHARMS
01 8SOLUTION/DROPS;OPHTHALMIC
02 31SPRAY, METERED;NASAL
01 16DISCN
02 6OTC
03 15RX
04 2Blank
01 1ASTELIN
02 4ASTEPRO
03 1ASTEPRO ALLERGY
04 25AZELASTINE HYDROCHLORIDE
05 2AZELASTINE HYDROCHLORIDE ALLERGY
06 2AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
07 1AZELASTINE HYDROCHLORIDE CHILDRENS ALLERGY
08 1CHILDRENS ASTEPRO ALLERGY
09 1DYMISTA
10 1OPTIVAR
01 31No
02 6Yes
03 2Blank
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 :
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 : DISCN
RLD : No
TE Code :
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 :
Brand Name : AZELASTINE HYDROCHLORIDE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.05%
Approval Date : 2010-06-21
Application Number : 78738
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Dosage Strength : 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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
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 :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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 :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
