FDA.reportPublic FDA data

Application 205437

Type
NDA
Sponsor
AMGEN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OTEZLAAPREMILASTTABLET;ORAL10MGYesNo
002OTEZLAAPREMILASTTABLET;ORAL20MGYesNo
003OTEZLAAPREMILASTTABLET;ORAL30MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-137OtezlaapremilastAmgen IncNDACurrent
55513-137OtezlaapremilastAmgen IncNDACurrent
55513-137OtezlaapremilastAmgen IncNDACurrent
55513-137OtezlaapremilastAmgen IncNDACurrent
55513-137OtezlaapremilastAmgen IncNDACurrent
55513-137OtezlaapremilastAmgen IncNDACurrent
55513-137OtezlaapremilastAmgen IncNDACurrent
55513-137OtezlaapremilastAmgen IncNDACurrent
55513-137OtezlaapremilastAmgen IncNDACurrent
55513-137OtezlaapremilastAmgen IncNDACurrent
55513-369OtezlaapremilastAmgen IncNDACurrent
55513-369OtezlaapremilastAmgen IncNDACurrent
55513-369OtezlaapremilastAmgen IncNDACurrent
55513-369OtezlaapremilastAmgen IncNDACurrent
55513-369OtezlaapremilastAmgen IncNDACurrent
55513-369OtezlaapremilastAmgen IncNDACurrent
55513-369OtezlaapremilastAmgen IncNDACurrent
55513-369OtezlaapremilastAmgen IncNDACurrent
55513-369OtezlaapremilastAmgen IncNDACurrent
55513-369OtezlaapremilastAmgen IncNDACurrent
55513-485OtezlaapremilastAmgen IncNDACurrent
55513-485OtezlaapremilastAmgen IncNDACurrent
55513-485OtezlaapremilastAmgen IncNDACurrent
55513-485OtezlaapremilastAmgen IncNDACurrent
55513-485OtezlaapremilastAmgen IncNDACurrent
55513-485OtezlaapremilastAmgen IncNDACurrent
55513-485OtezlaapremilastAmgen IncNDACurrent
55513-485OtezlaapremilastAmgen IncNDACurrent
55513-485OtezlaapremilastAmgen IncNDACurrent
55513-485OtezlaapremilastAmgen IncNDACurrent
59572-630OTEZLAapremilastCelgene CorporationNDACurrent
59572-630OTEZLAapremilastCelgene CorporationNDACurrent
59572-630OTEZLAapremilastCelgene CorporationNDACurrent
59572-630OTEZLAapremilastCelgene CorporationNDACurrent
59572-631OTEZLAapremilastCelgene CorporationNDACurrent
59572-631OTEZLAapremilastCelgene CorporationNDACurrent
59572-631OTEZLAapremilastCelgene CorporationNDACurrent
59572-631OTEZLAapremilastCelgene CorporationNDACurrent
59572-632OTEZLAapremilastCelgene CorporationNDACurrent
59572-632OTEZLAapremilastCelgene CorporationNDACurrent
59572-632OTEZLAapremilastCelgene CorporationNDACurrent
59572-632OTEZLAapremilastCelgene CorporationNDACurrent
70518-3155OtezlaapremilastREMEDYREPACK INC.NDACurrent
70518-3155OtezlaapremilastREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85116SUPPL 2026-02-24
84619SUPPL 2025-12-31
84597SUPPL 2025-12-30
82933SUPPL 2025-07-25
82921SUPPL 2025-07-25
78281SUPPL 2024-04-26
78273SUPPL 2024-04-26
76671SUPPL 2023-11-28
74853SUPPL 2023-07-21
74843SUPPL 2023-07-21
69734SUPPL2021-12-21
69730SUPPL2021-12-21
62553SUPPL2020-04-13
62551SUPPL2020-04-13
59392SUPPL2019-07-22
59381SUPPL2019-07-19
48897SUPPL2017-07-05
48875SUPPL2017-06-30
19648SUPPL2015-12-28
32678SUPPL2015-12-22
22990ORIG2014-04-17
40471ORIG2014-03-25
32677ORIG2014-03-25