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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 3Torrent Pharmaceuticals Limited

20 1Viatris

21 2Zydus Pharmaceuticals

22 2Blank

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PharmaCompass

01

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Fi Europe 2024
Not Confirmed

ROFLUMILAST

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

Breckenridge Pharmaceutical

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Regulatory Info : RX

Registration Country : USA

ROFLUMILAST

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

Strides Pharma Science

03

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Fi Europe 2024
Not Confirmed

ROFLUMILAST

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

Breckenridge Pharmaceutical

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Regulatory Info : RX

Registration Country : USA

ROFLUMILAST

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

Strides Pharma Science

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Regulatory Info :

Registration Country : India

Roflumilast

Brand Name :

Dosage Form : Tablet

Dosage Strength : 500MCG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Strides Pharma Science

06

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

ROFLUMILAST

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

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07

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

ROFLUMILAST

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

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08

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

ROFLUMILAST

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

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09

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

ROFLUMILAST

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

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10

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

ROFLUMILAST

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

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11

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
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ROFLUMILAST

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

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12

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

ROFLUMILAST

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

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13

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

ROFLUMILAST

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

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14

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

ROFLUMILAST

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

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15

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

ROFLUMILAST

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

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16

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

Roflumilast

Brand Name :

Dosage Form : Tablet

Dosage Strength : 0.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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17

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

ROFLUMILAST

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

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18

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

ROFLUMILAST

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

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19

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
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Roflumilast

Brand Name :

Dosage Form : TABLET

Dosage Strength : 500MCG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic CTD, BE- Available

Registration Country : Jordan

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20

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

ROFLUMILAST

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

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21

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

ROFLUMILAST

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

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22

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
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Roflumilast

Brand Name :

Dosage Form : TABLET

Dosage Strength : 0.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic EU CTD

Registration Country : India

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23

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

ROFLUMILAST

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

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24

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
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roflumilast

Brand Name : Daliresp

Dosage Form : FILM COATED PILL

Dosage Strength : 500 MICROGRAMS

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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25

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
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roflumilast

Brand Name : Daxas

Dosage Form : FILM COATED PILL

Dosage Strength : 500 MICROGRAMS

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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26

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
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roflumilast

Brand Name : Libertek

Dosage Form : FILM COATED PILL

Dosage Strength : 500 MICROGRAMS

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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27

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

ROFLUMILAST

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

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28

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

ROFLUMILAST

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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29

Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

ROFLUMILAST

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

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Fi Europe 2024
Not Confirmed
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Fi Europe 2024
Not Confirmed

ROFLUMILAST

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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