Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 200535
Company: GENUS LIFESCIENCES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription AA Yes Yes
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription AA Yes No
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/2010/200535s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200535s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200535s000_oxycodone_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200535Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200535s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200535Orig1s014s015ltr.pdf
09/18/2018 SUPPL-14 REMS - PROPOSAL - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200535s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200535Orig1s014s015ltr.pdf
12/16/2016 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200535s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200535Orig1s011ltr.pdf
09/01/2015 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/20/2014 SUPPL-9 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200535s009lbl.pdf
08/22/2013 SUPPL-8 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200535s006s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200535Orig1s006,s008ltr.pdf
10/08/2013 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/22/2013 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200535s006s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200535Orig1s006,s008ltr.pdf
01/25/2012 SUPPL-4 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200535s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/18/2018 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200535s014s015lbl.pdf
09/18/2018 SUPPL-14 REMS - PROPOSAL - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200535s014s015lbl.pdf
12/16/2016 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200535s011lbl.pdf
06/20/2014 SUPPL-9 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200535s009lbl.pdf
08/22/2013 SUPPL-8 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200535s006s008lbl.pdf
08/22/2013 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200535s006s008lbl.pdf
10/20/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200535s000lbl.pdf

OXYCODONE HYDROCHLORIDE

SOLUTION;ORAL; 100MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 208593 ABHAI LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 211749 ALKEM LABS LTD
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 203447 ANI PHARMS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 209021 ASCENT PHARMS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription Yes AA 200535 GENUS LIFESCIENCES
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 208795 HI TECH
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 204092 MAYNE PHARMA INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 204603 NOVEL LABS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 206822 PHARM ASSOC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 210758 SPECGX LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 202537 VISTAPHARM
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 209897 WES PHARMA INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;ORAL Prescription No AA 203208 WEST-WARD PHARMS INT

SOLUTION;ORAL; 5MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 208593 ABHAI LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 211748 ALKEM LABS LTD
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 204979 ANI PHARMS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 209021 ASCENT PHARMS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription Yes AA 200535 GENUS LIFESCIENCES
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 208817 HI TECH
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 210758 SPECGX LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription Yes AA 201194 VISTAPHARM
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 207511 WES PHARMA INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 204037 WEST-WARD PHARMS INT
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 206456 WOCKHARDT BIO AG

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