01 2Breckenridge Pharmaceutical
02 3Strides Pharma Science
03 22care4
04 1ARCUTIS CANADA, INC.
05 2Alkem Laboratories
06 3Arcutis Biotherapeutics
07 8AstraZeneca
08 1Aurobindo Pharma Limited
09 2Hetero Drugs
10 1KMS Health Center
11 1MS Pharma
12 2MSN Laboratories
13 2Micro Labs Limited
14 2ORIFARM GROUP AS
15 1Orchid Pharma
16 1Precise Group
17 1Prinston
18 4Takeda Pharmaceutical
19 4Torrent Pharmaceuticals Limited
20 1Viatris
21 2Zydus Pharmaceuticals
22 2Blank
01 4Antic-calc Tablet, Film Coated
02 1CREAM
03 2CREAM;TOPICAL
04 1FCT
05 3FILM COATED PILL
06 1FOAM;TOPICAL
07 2Film Coated Tablet
08 2Filmtabl
09 1Roflumilast 500Mcg 30 Joined' Oral Use
10 3TABLET
11 21TABLET;ORAL
12 5Tablet
13 2Tablet, film-coated
01 3DISCN
02 2Generic
03 1Generic CTD, BE- Available
04 1Generic EU CTD
05 1Originator
06 2Prescription
07 21RX
08 17Blank
01 130 Daxas 500Mcg Film-Coated Tablets
02 130 Libertek 500Mcg Film-Coated Tablets
03 2DALIRESP
04 1DAXAS
05 1Daliresp
06 8Daxas
07 1Daxas 500 µg
08 1Libertek
09 2Quadruple
10 19ROFLUMILAST
11 4ZORYVE
12 7Blank
01 2Canada
02 6India
03 1Italy
04 1Jordan
05 6Norway
06 1South Africa
07 2Spain
08 3Sweden
09 2Switzerland
10 24USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 500MCG
Packaging :
Approval Date : 2018-10-03
Application Number : 208236
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 500MCG
Packaging :
Approval Date : 2020-03-30
Application Number : 208247
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 250MCG
Packaging :
Approval Date : 2023-10-19
Application Number : 208236
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 250MCG
Packaging :
Approval Date : 2023-06-20
Application Number : 208247
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 500MCG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 250MCG
Packaging :
Approval Date : 2023-04-18
Application Number : 212490
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 500MCG
Packaging :
Approval Date : 2023-04-18
Application Number : 212490
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZORYVE
Dosage Form : CREAM;TOPICAL
Dosage Strength : 0.3%
Packaging :
Approval Date : 2022-07-29
Application Number : 215985
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZORYVE
Dosage Form : CREAM;TOPICAL
Dosage Strength : 0.15%
Packaging :
Approval Date : 2024-07-09
Application Number : 215985
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZORYVE
Dosage Form : FOAM;TOPICAL
Dosage Strength : 0.3%
Packaging :
Approval Date : 2023-12-15
Application Number : 217242
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DALIRESP
Dosage Form : TABLET;ORAL
Dosage Strength : 500MCG
Packaging :
Approval Date : 2011-02-28
Application Number : 22522
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DALIRESP
Dosage Form : TABLET;ORAL
Dosage Strength : 250MCG
Packaging :
Approval Date : 2018-01-23
Application Number : 22522
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 500MCG
Packaging :
Approval Date : 2023-04-17
Application Number : 213298
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 500MCG
Packaging :
Approval Date : 2018-11-23
Application Number : 208213
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 250MCG
Packaging :
Approval Date : 2023-04-18
Application Number : 208213
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 500MCG
Packaging :
Approval Date : 2019-03-22
Application Number : 208180
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 250MCG
Packaging :
Approval Date : 2023-04-18
Application Number : 208180
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Generic CTD, BE- Available
Registration Country : Jordan
Brand Name :
Dosage Form : TABLET
Dosage Strength : 500MCG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic CTD, BE- Available
Registration Country : Jordan
Regulatory Info : RX
Registration Country : USA
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 250MCG
Packaging :
Approval Date : 2022-09-07
Application Number : 208256
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 500MCG
Packaging :
Approval Date : 2022-09-07
Application Number : 208256
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Generic EU CTD
Registration Country : India
Brand Name :
Dosage Form : TABLET
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic EU CTD
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 500MCG
Packaging :
Approval Date : 2022-05-10
Application Number : 208299
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : Daliresp
Dosage Form : FILM COATED PILL
Dosage Strength : 500 MICROGRAMS
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Daxas
Dosage Form : FILM COATED PILL
Dosage Strength : 500 MICROGRAMS
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Libertek
Dosage Form : FILM COATED PILL
Dosage Strength : 500 MICROGRAMS
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 500MCG
Packaging :
Approval Date : 2018-08-06
Application Number : 208272
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 250MCG
Packaging :
Approval Date : 2024-10-18
Application Number : 208272
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 500MCG
Packaging :
Approval Date : 2018-07-13
Application Number : 208257
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 500MCG
Packaging :
Approval Date : 2022-02-10
Application Number : 208303
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 250MCG
Packaging :
Approval Date : 2023-04-18
Application Number : 208303
Regulatory Info : RX
Registration Country : USA
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