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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017116
Company: SPECGX LLC

Other Important Information from FDA

Products on NDA 17116

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHADOSE	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE;ORAL	Prescription	AA	Yes	Yes

Labels for NDA 017116

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-48	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017116s048lbl.pdf
12/22/2025	SUPPL-48	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017116s048lbl.pdf
12/15/2023	SUPPL-45	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017116s045lbl.pdf
09/13/2021	SUPPL-43	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017116Orig1s043Lbl.pdf
06/02/2021	SUPPL-41	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017116s041lbl.pdf
10/07/2019	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017116s038lbl.pdf
02/01/2018	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017116s032lbl.pdf
12/16/2016	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017116s029lbl.pdf
12/16/2016	SUPPL-29	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017116s029lbl.pdf
12/16/2016	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017116s029lbl.pdf
02/04/2008	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017116s021lbl.pdf
05/26/2005	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017116s015,016lbl.pdf
05/26/2005	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017116s015,016lbl.pdf

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