Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017116
Company: SPECGX LLC
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 |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017116s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017116Orig1s045ltr.pdf | |
| 09/13/2021 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017116Orig1s043Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017116Orig1s043ltr.pdf | |
| 06/02/2021 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017116s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017116Orig1s041ltr.pdf | |
| 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-Medication Guide, Labeling-Package Insert |
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 |
|---|---|---|---|---|---|
| 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 |
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 | 212093 | LANNETT CO INC |
| 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 LLC |
| 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 |