Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
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01 3Strides Pharma Science
02 22care4
03 2ARCUTIS CANADA, INC.
04 2Alkem Laboratories
05 3Arcutis Biotherapeutics
06 8AstraZeneca
07 2Aurobindo Pharma Limited
08 2Hetero Drugs
09 1KMS Health Center
10 1MS Pharma
11 2MSN Laboratories
12 2Micro Labs Limited
13 1NORVIUM BIOSCIENCE
14 2ORIFARM GROUP AS
15 1Orchid Pharma
16 1Precise Group
17 1Prinston
18 2Senores Pharmaceuticals
19 4Takeda Pharmaceutical
20 4Torrent Pharmaceuticals Limited
21 2Zydus Pharmaceuticals
22 2Blank
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01 4Antic-calc Tablet, Film Coated
02 1CREAM
03 2CREAM;TOPICAL
04 1FCT
05 3FILM COATED PILL
06 1FOAM
07 1FOAM;TOPICAL
08 2Film Coated Tablet
09 2Filmtabl
10 1Roflumilast 500Mcg 30 Joined' Oral Use
11 3TABLET
12 22TABLET;ORAL
13 5Tablet
14 2Tablet, film-coated
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01 3DISCN
02 2Generic
03 1Generic CTD, BE- Available
04 1Generic EU CTD
05 1Originator
06 3Prescription
07 22RX
08 17Blank
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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 20ROFLUMILAST
11 5ZORYVE
12 7Blank
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01 3Canada
02 6India
03 1Italy
04 1Jordan
05 6Norway
06 1South Africa
07 2Spain
08 3Sweden
09 2Switzerland
10 25USA
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 : 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 : 250MCG
Packaging :
Approval Date : 2025-01-31
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 : 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 : 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 :
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 : 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 : 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
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
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