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Athena Athena

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Approved Drug Products containing Roflumilast listed in the FDA Orange Book. Original Data : FDA Website

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01 STRIDES PHARMA (2)

02 ALKEM LABS LTD (2)

03 ARCUTIS (2)

04 ASTRAZENECA (2)

05 AUROBINDO PHARMA LTD (1)

06 BRECKENRIDGE (2)

07 HETERO LABS LTD III (2)

08 MICRO LABS (2)

09 MSN (2)

10 MYLAN (1)

11 PRINSTON INC (1)

12 TORRENT (1)

13 ZYDUS PHARMS (2)

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01 CREAM;TOPICAL (1)

02 FOAM;TOPICAL (1)

03 TABLET;ORAL (20)

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01 DISCN (2)

02 RX (20)

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01 DALIRESP (2)

02 ROFLUMILAST (18)

03 ZORYVE (2)

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01 No (18)

02 Yes (4)

TABLET;ORAL
500MCG
2020-03-30
208247
ROFLUMILAST
RX
No
AB
TABLET;ORAL
250MCG
2023-06-20
208247
ROFLUMILAST
RX
No
AB
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TABLET;ORAL
500MCG
2011-02-28
22522
DALIRESP
RX
Yes
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TABLET;ORAL
250MCG
2018-01-23
22522
DALIRESP
RX
Yes
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TABLET;ORAL
500MCG
2018-10-03
208236
ROFLUMILAST
DISCN
No
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TABLET;ORAL
250MCG
2023-10-19
208236
ROFLUMILAST
RX
No
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TABLET;ORAL
500MCG
2018-11-23
208213
ROFLUMILAST
RX
No
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TABLET;ORAL
250MCG
2023-04-18
208213
ROFLUMILAST
RX
No
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TABLET;ORAL
500MCG
2019-03-22
208180
ROFLUMILAST
RX
No
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TABLET;ORAL
250MCG
2023-04-18
208180
ROFLUMILAST
RX
No
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