Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021217
Company: SPECGX LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EXALGO HYDROMORPHONE HYDROCHLORIDE 8MG TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
EXALGO HYDROMORPHONE HYDROCHLORIDE 12MG TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
EXALGO HYDROMORPHONE HYDROCHLORIDE 16MG TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
EXALGO HYDROMORPHONE HYDROCHLORIDE 32MG TABLET, EXTENDED RELEASE;ORAL Discontinued None 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
03/01/2010 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021217lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021217s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021217s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021217s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/07/2019 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021217s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021217Orig1s025ltr.pdf
09/18/2018 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021217s023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021217Orig1s023s024ltr.pdf
09/18/2018 SUPPL-23 REMS - MODIFIED - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021217s023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021217Orig1s023s024ltr.pdf
05/26/2017 SUPPL-21 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021217Orig1s021ltr.pdf
09/30/2016 SUPPL-20 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021217Orig1s020ltr.pdf
12/16/2016 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021217s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021217Orig1s019ltr.pdf
04/20/2016 SUPPL-17 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021217Orig1s017ltr.pdf
06/26/2015 SUPPL-15 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021217Orig1s015ltr.pdf
08/19/2014 SUPPL-14 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021217Orig1s014ltr.pdf
04/16/2014 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021217s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021217Orig1s013ltr.pdf
06/17/2014 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021217Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021217Orig1s012ltr.pdf
06/02/2015 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021217s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021217Orig1s009ltr.pdf
04/15/2013 SUPPL-6 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021217Orig1s006ltr.pdf
03/18/2013 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021217s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021217Orig1s005ltr.pdf
08/24/2012 SUPPL-4 Labeling-Package Insert, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021217s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021217Orig1s004ltr.pdf
07/09/2012 SUPPL-2 Labeling, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021217s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021217Orig1s002ltr.pdf
03/24/2010 SUPPL-1 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021217s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/07/2019 SUPPL-25 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021217s025lbl.pdf
10/07/2019 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021217s025lbl.pdf
09/18/2018 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021217s023s024lbl.pdf
09/18/2018 SUPPL-23 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021217s023s024lbl.pdf
12/16/2016 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021217s019lbl.pdf
06/02/2015 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021217s009lbl.pdf
06/17/2014 SUPPL-12 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021217Orig1s012lbl.pdf
06/17/2014 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021217Orig1s012lbl.pdf
06/17/2014 SUPPL-12 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021217Orig1s012lbl.pdf
04/16/2014 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021217s013lbl.pdf
03/18/2013 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021217s005lbl.pdf
08/24/2012 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021217s004lbl.pdf
08/24/2012 SUPPL-4 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021217s004lbl.pdf
07/09/2012 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021217s002lbl.pdf
07/09/2012 SUPPL-2 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021217s002lbl.pdf
03/01/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021217lbl.pdf

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