01 1AMNEAL
02 1AMNEAL PHARMS
03 1ANDA REPOSITORY
04 2APOTEX
05 2AUROBINDO PHARMA
06 3COSETTE
07 2ENCUBE
08 3FOUGERA PHARMS
09 2GLENMARK PHARMS INC
10 1GLENMARK PHARMS LTD
11 1GLENMARK SPECLT
12 1INTERSECT ENT INC
13 4ORGANON
14 9ORGANON LLC
15 1PADAGIS ISRAEL
16 1PADAGIS US
17 1PERRIGO PHARMA INTL
18 3TARO
19 1TORRENT
01 6AEROSOL, METERED;INHALATION
02 7CREAM;TOPICAL
03 1IMPLANT;IMPLANTATION
04 7LOTION;TOPICAL
05 8OINTMENT;TOPICAL
06 2POWDER;INHALATION
07 9SPRAY, METERED;NASAL
01 14DISCN
02 1OTC
03 24RX
04 1Blank
01 3ASMANEX HFA
02 2ASMANEX TWISTHALER
03 3DULERA
04 4ELOCON
05 24MOMETASONE FUROATE
06 1NASONEX
07 1NASONEX 24HR ALLERGY
08 1RYALTRIS
09 1SINUVA
01 24No
02 15Yes
03 1Blank
RLD : Yes
TE Code :
Brand Name : ELOCON
Dosage Form : OINTMENT;TOPICAL
Dosage Strength : 0.1%
Approval Date : 1987-04-30
Application Number : 19543
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : ELOCON
Dosage Form : CREAM;TOPICAL
Dosage Strength : 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1987-05-06
Application Number : 19625
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : ELOCON
Dosage Form : CREAM;TOPICAL
Dosage Strength : 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2013-04-19
Application Number : 19625
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ELOCON
Dosage Form : LOTION;TOPICAL
Dosage Strength : 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1989-03-30
Application Number : 19796
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NASONEX
Dosage Form : SPRAY, METERED;NASAL
Dosage Strength : 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1997-10-01
Application Number : 20762
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ASMANEX TWISTHALER
Dosage Form : POWDER;INHALATION
Dosage Strength : 0.22MG/INH
Approval Date : 2005-03-30
Application Number : 21067
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ASMANEX TWISTHALER
Dosage Form : POWDER;INHALATION
Dosage Strength : 0.11MG/INH
Approval Date : 2008-02-01
Application Number : 21067
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;0.1MG/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 :
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