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01 2STRIDES PHARMA
02 2ALKEM LABS LTD
03 4ARCUTIS
04 2ASTRAZENECA
05 2AUROBINDO PHARMA LTD
06 2HETERO LABS LTD III
07 2MICRO LABS
08 2MSN
09 1PHARMOBEDIENT
10 1PRINSTON INC
11 2SENORES PHARMS
12 2TORRENT
13 2ZYDUS PHARMS
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01 3CREAM;TOPICAL
02 1FOAM;TOPICAL
03 22TABLET;ORAL
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01 4DISCN
02 22RX
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01 2DALIRESP
02 20ROFLUMILAST
03 4ZORYVE
01 20No
02 6Yes
RLD : No
TE Code : AB
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 500MCG
Approval Date : 2020-03-30
Application Number : 208247
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 250MCG
Approval Date : 2023-06-20
Application Number : 208247
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
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RLD : Yes
TE Code : AB
Brand Name : DALIRESP
Dosage Form : TABLET;ORAL
Dosage Strength : 500MCG
Approval Date : 2011-02-28
Application Number : 22522
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB

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RLD : Yes
TE Code : AB
Brand Name : DALIRESP
Dosage Form : TABLET;ORAL
Dosage Strength : 250MCG
Approval Date : 2018-01-23
Application Number : 22522
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB

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RLD : No
TE Code : AB
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 500MCG
Approval Date : 2018-11-23
Application Number : 208213
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 250MCG
Approval Date : 2023-04-18
Application Number : 208213
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 500MCG
Approval Date : 2019-03-22
Application Number : 208180
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 250MCG
Approval Date : 2023-04-18
Application Number : 208180
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code :
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 500MCG
Approval Date : 2018-10-03
Application Number : 208236
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code :
Brand Name : ROFLUMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 250MCG
Approval Date : 2023-10-19
Application Number : 208236
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
