Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 200535
Company: GENUS LIFESCIENCES
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 |
---|---|---|---|---|---|
04/19/2024 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200535s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/200535Orig1s023ltr.pdf | |
12/15/2023 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/200535s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/200535Orig1s022ltr.pdf | |
03/04/2021 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200535s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/200535Orig1s019ltr.pdf | |
07/21/2021 | SUPPL-17 | 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,%20200535Orig1s017ltr.pdf | |
10/07/2019 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200535s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/200535Orig1s016ltr.pdf | |
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 |
---|---|---|---|---|---|
04/19/2024 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200535s023lbl.pdf | |
12/15/2023 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/200535s022lbl.pdf | |
07/21/2021 | SUPPL-17 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200534s010,200535s017lbl.pdf | |
03/04/2021 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200535s019lbl.pdf | |
10/07/2019 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200535s016lbl.pdf | |
10/07/2019 | SUPPL-16 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200535s016lbl.pdf | |
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 | 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 | 206822 | PHARM ASSOC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 213761 | QUAGEN |
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 | 209897 | WES PHARMA INC |
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 |
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 | 204037 | HIKMA |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 206914 | PHARM ASSOC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 213761 | QUAGEN |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 210758 | SPECGX LLC |
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 207511 | WES PHARMA INC |