Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017116
Company: SPECGX LLC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/14/1973 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/07/2019 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017116s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017116Orig1s038ltr.pdf
02/01/2018 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017116s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017116Orig1s032ltr.pdf
12/16/2016 SUPPL-29 Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017116s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017116Orig1s029ltr.pdf
09/22/2014 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/02/2014 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/04/2008 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017116s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017116s021ltr.pdf
08/03/2005 SUPPL-19 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017116s018,019ltr.pdf
08/03/2005 SUPPL-18 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017116s018,019ltr.pdf
05/26/2005 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017116s015,016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017116s015,016ltr.pdf
05/26/2005 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017116s015,016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017116s015,016ltr.pdf
03/27/2002 SUPPL-14 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17116s014ltr.pdf
04/03/2000 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

04/20/1993 SUPPL-12 Labeling

Label is not available on this site.

09/07/1982 SUPPL-10 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/25/1981 SUPPL-9 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/06/1980 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/06/1980 SUPPL-7 Labeling

Label is not available on this site.

02/11/1977 SUPPL-2 Labeling

Label is not available on this site.

08/06/1976 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-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
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

METHADOSE

CONCENTRATE;ORAL; 10MG/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE;ORAL Prescription No AA 040180 HIKMA
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE;ORAL Prescription No AA 207368 SPECGX LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE;ORAL Prescription No AA 040088 VISTAPHARM
METHADONE HYDROCHLORIDE INTENSOL METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE;ORAL Prescription No AA 089897 HIKMA
METHADOSE METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE;ORAL Prescription Yes AA 017116 SPECGX LLC

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