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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205437
Company: AMGEN INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OTEZLA APREMILAST 10MG TABLET;ORAL Prescription AB Yes No
OTEZLA APREMILAST 20MG TABLET;ORAL Prescription AB Yes No
OTEZLA APREMILAST 30MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/21/2014 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205437s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205437Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205437Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/20/2021 SUPPL-11 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205437s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205437Orig1s011ltr.pdf
04/10/2020 SUPPL-8 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205437Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205437Orig1s008ltr.pdf
07/19/2019 SUPPL-7 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205437Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205437Orig1s007ltr.pdf
06/29/2017 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205437s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205437Orig1s006ltr.pdf
12/21/2015 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205437s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205437Orig1s005ltr.pdf
04/27/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/19/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/28/2014 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/22/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/20/2021 SUPPL-11 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205437s011lbl.pdf
04/10/2020 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205437Orig1s008lbl.pdf
07/19/2019 SUPPL-7 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205437Orig1s007lbl.pdf
06/29/2017 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205437s006lbl.pdf
12/21/2015 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205437s005lbl.pdf
03/21/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205437s000lbl.pdf

OTEZLA

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APREMILAST APREMILAST 10MG TABLET;ORAL Prescription No AB 211761 ALKEM LABS LTD
APREMILAST APREMILAST 10MG TABLET;ORAL Prescription No AB 211897 TEVA PHARMS USA INC
OTEZLA APREMILAST 10MG TABLET;ORAL Prescription Yes AB 205437 AMGEN INC

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APREMILAST APREMILAST 20MG TABLET;ORAL Prescription No AB 211761 ALKEM LABS LTD
APREMILAST APREMILAST 20MG TABLET;ORAL Prescription No AB 211897 TEVA PHARMS USA INC
OTEZLA APREMILAST 20MG TABLET;ORAL Prescription Yes AB 205437 AMGEN INC

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APREMILAST APREMILAST 30MG TABLET;ORAL Prescription No AB 211761 ALKEM LABS LTD
APREMILAST APREMILAST 30MG TABLET;ORAL Prescription No AB 211897 TEVA PHARMS USA INC
OTEZLA APREMILAST 30MG TABLET;ORAL Prescription Yes AB 205437 AMGEN INC
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