Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021011
Company: SPECGX LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROXICODONE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription AB Yes Yes
ROXICODONE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription AB Yes No
ROXICODONE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB 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
08/31/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-011_Roxicodone.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021011s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021011Orig1s008s009ltr.pdf
09/18/2018 SUPPL-8 REMS - PROPOSAL - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021011s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021011Orig1s008s009ltr.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/2016/021011s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021011Orig1s006ltr.pdf
05/15/2009 SUPPL-3 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021011s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021011s003ltr.pdf
02/20/2009 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021011s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021011s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/18/2018 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021011s008s009lbl.pdf
09/18/2018 SUPPL-8 REMS - PROPOSAL - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021011s008s009lbl.pdf
12/16/2016 SUPPL-6 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021011s006lbl.pdf
12/16/2016 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021011s006lbl.pdf
12/16/2016 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021011s006lbl.pdf
05/15/2009 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021011s003lbl.pdf
05/15/2009 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021011s003lbl.pdf
02/20/2009 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021011s002lbl.pdf
08/31/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21011lbl.pdf

ROXICODONE

TABLET;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 076636 ACTAVIS ELIZABETH
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 202116 ALVOGEN MALTA
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 203638 AMNEAL PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 207418 ASCENT PHARMS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 202160 AUROLIFE PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 091393 AVANTHI INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 090895 EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 202662 EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 091313 MAYNE PHARMA INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 077290 NESHER PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 204021 NOVEL LABS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 207119 NUVO PHARM
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 091490 RHODES PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 076758 SPECGX LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 090659 SUN PHARM INDS INC
ROXICODONE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription Yes AB 021011 SPECGX LLC

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 076636 ACTAVIS ELIZABETH
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 202116 ALVOGEN MALTA
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 203638 AMNEAL PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 207418 ASCENT PHARMS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 202160 AUROLIFE PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 091393 AVANTHI INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 090895 EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 202662 EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 091313 MAYNE PHARMA INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 077290 NESHER PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 204021 NOVEL LABS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 207119 NUVO PHARM
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 091490 RHODES PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 076758 SPECGX LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 090659 SUN PHARM INDS INC
ROXICODONE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription Yes AB 021011 SPECGX LLC

TABLET;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 TABLET;ORAL Prescription No AB 076636 ACTAVIS ELIZABETH
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202116 ALVOGEN MALTA
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 203638 AMNEAL PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202160 AUROLIFE PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 091393 AVANTHI INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090895 EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202662 EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 091313 MAYNE PHARMA INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 077290 NESHER PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 204021 NOVEL LABS INC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 207119 NUVO PHARM
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 091490 RHODES PHARMS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 076758 SPECGX LLC
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090659 SUN PHARM INDS INC
ROXICODONE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 021011 SPECGX LLC

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