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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021217
Company: SPECGX LLC

Medication Guide

REMS

Summary Review

Products on NDA 021217

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EXALGO	HYDROMORPHONE HYDROCHLORIDE	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
EXALGO	HYDROMORPHONE HYDROCHLORIDE	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
EXALGO	HYDROMORPHONE HYDROCHLORIDE	16MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
EXALGO	HYDROMORPHONE HYDROCHLORIDE	32MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021217

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-Package Insert, Labeling-Medication Guide	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-Package Insert, Labeling-Medication Guide, 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	REMS-Modified, Labeling	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

Labels for NDA 021217

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2019	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021217s025lbl.pdf
10/07/2019	SUPPL-25	Labeling-Medication Guide	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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021217Orig1s012lbl.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	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	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021217s002lbl.pdf
07/09/2012	SUPPL-2	Labeling	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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