Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG/5ML | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 08/30/1982 | ORIG-1 | Approval |
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-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/02/2021 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/09/2019 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-38 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 02/01/2018 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2018 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/26/2017 | SUPPL-35 | REMS-Modified |
Label is not available on this site. |
||
| 03/10/2017 | SUPPL-33 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/30/2016 | SUPPL-32 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/20/2016 | SUPPL-29 | REMS-Modified |
Label is not available on this site. |
||
| 12/15/2016 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/26/2015 | SUPPL-27 | REMS-Modified |
Label is not available on this site. |
||
| 08/19/2014 | SUPPL-26 | REMS-Modified |
Label is not available on this site. |
||
| 04/16/2014 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087997Orig1s024lbl.pdf | |
| 04/15/2013 | SUPPL-23 | REMS-Modified |
Label is not available on this site. |
||
| 07/09/2012 | SUPPL-22 | REMS-Proposal |
Label is not available on this site. |
||
| 07/09/2012 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/02/2008 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/07/2007 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 02/01/2000 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/03/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/03/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/24/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/24/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/31/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/16/2014 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087997Orig1s024lbl.pdf |
METHADONE HYDROCHLORIDE
SOLUTION;ORAL; 10MG/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG/5ML | SOLUTION;ORAL | Prescription | Yes | AA | 087997 | HIKMA |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 207537 | SPECGX LLC |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 090707 | VISTAPHARM LLC |