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New Drug Application (NDA): 200534
Company: GENUS LIFESCIENCES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG CAPSULE;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
10/20/2010 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200534s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200534s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200534s000_oxycodone_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200534Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2021 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200534s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/200534Orig1s011ltr.pdf
07/21/2021 SUPPL-10 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200534s010,200535s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/200534Orig1s010, 200535Orig1s017ltr.pdf
10/07/2019 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200534s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/200534Orig1s009ltr.pdf
09/18/2018 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200534s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200534Orig1s007s008ltr.pdf
09/18/2018 SUPPL-7 REMS - PROPOSAL - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200534s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200534Orig1s007s008ltr.pdf
12/16/2016 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200534s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200534Orig1s006ltr.pdf
11/16/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/02/2014 SUPPL-4 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
07/21/2021 SUPPL-10 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200534s010,200535s017lbl.pdf
03/04/2021 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200534s011lbl.pdf
10/07/2019 SUPPL-9 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200534s009lbl.pdf
10/07/2019 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200534s009lbl.pdf
09/18/2018 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200534s007s008lbl.pdf
09/18/2018 SUPPL-7 REMS - PROPOSAL - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200534s007s008lbl.pdf
12/16/2016 SUPPL-6 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200534s006lbl.pdf
12/16/2016 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200534s006lbl.pdf
12/16/2016 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200534s006lbl.pdf
10/20/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200534s000lbl.pdf

OXYCODONE HYDROCHLORIDE

CAPSULE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG CAPSULE;ORAL Prescription No AB 205177 ANI PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG CAPSULE;ORAL Prescription No AB 202773 AVANTHI INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG CAPSULE;ORAL Prescription Yes AB 200534 GENUS LIFESCIENCES
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG CAPSULE;ORAL Prescription No AB 203107 MAYNE PHARMA INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG CAPSULE;ORAL Prescription No AB 204752 NOVEL LABS INC
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