01 1ALEMBIC
02 3ASTRAZENECA
03 1ASTRAZENECA AB
04 1COVIS
05 1LEXENPHARM
06 1LUPIN
07 1MANKIND PHARMA
08 1MICRO LABS
09 2MYLAN
10 1MYLAN SPECLT
11 3NOVARTIS
12 3ORGANON LLC
13 1RITEDOSE CORP
14 1TEVA PHARMS USA INC
15 1WILSHIRE PHARMS INC
01 9AEROSOL, METERED;INHALATION
02 1POWDER, METERED;INHALATION
03 1POWDER; INHALATION
04 2POWDER;INHALATION
05 9SOLUTION;INHALATION
01 2DISCN
02 19RX
03 1Blank
01 1BEVESPI AEROSPHERE
02 2BREYNA
03 1BREZTRI AEROSPHERE
04 1DUAKLIR PRESSAIR
05 3DULERA
06 2FORADIL
07 1FORADIL CERTIHALER
08 8FORMOTEROL FUMARATE
09 1PERFOROMIST
10 2SYMBICORT
01 11No
02 10Yes
03 1Blank
RLD : Yes
TE Code : AB
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Brand Name : SYMBICORT
Dosage Form : AEROSOL, METERED;INHALATION
Dosage Strength : 0.08MG/INH;0.0045MG/INH
Approval Date : 2006-07-21
Application Number : 21929
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Brand Name : SYMBICORT
Dosage Form : AEROSOL, METERED;INHALATION
Dosage Strength : 0.16MG/INH;0.0045MG/INH
Approval Date : 2006-07-21
Application Number : 21929
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code :
Brand Name : FORADIL
Dosage Form : POWDER;INHALATION
Dosage Strength : 0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2001-02-16
Application Number : 20831
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD :
TE Code :
Brand Name : FORADIL
Dosage Form : POWDER; INHALATION
Dosage Strength : 0.012MG/INH
Approval Date :
Application Number : 21279
RX/OTC/DISCN :
RLD :
TE Code :
RLD : No
TE Code :
Brand Name : FORADIL CERTIHALER
Dosage Form : POWDER;INHALATION
Dosage Strength : 0.0085MG/INH
Approval Date : 2006-12-15
Application Number : 21592
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
FORMOTEROL FUMARATE; MOMETASONE FUROATE
Brand Name : DULERA
Dosage Form : AEROSOL, METERED;INHALATION
Dosage Strength : 0.005MG/INH;0.1MG/INH
Approval Date : 2010-06-22
Application Number : 22518
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
FORMOTEROL FUMARATE; MOMETASONE FUROATE
Brand Name : DULERA
Dosage Form : AEROSOL, METERED;INHALATION
Dosage Strength : 0.005MG/INH;0.2MG/INH
Approval Date : 2010-06-22
Application Number : 22518
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
FORMOTEROL FUMARATE; MOMETASONE FUROATE
Brand Name : DULERA
Dosage Form : AEROSOL, METERED;INHALATION
Dosage Strength : 0.005MG/INH;0.05MG/INH
Approval Date : 2019-08-12
Application Number : 22518
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code : AN
Brand Name : FORMOTEROL FUMARATE
Dosage Form : SOLUTION;INHALATION
Dosage Strength : 0.02MG/2ML
Approval Date : 2021-06-22
Application Number : 91141
RX/OTC/DISCN : RX
RLD : No
TE Code : AN
RLD : Yes
TE Code : AN
Brand Name : PERFOROMIST
Dosage Form : SOLUTION;INHALATION
Dosage Strength : 0.02MG/2ML
Approval Date : 2007-05-11
Application Number : 22007
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AN
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