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 | TABLET;ORAL | Prescription | AA | No | No |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | AA | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/08/1983 | 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 |
|---|---|---|---|---|---|
| 12/22/2025 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2024 | SUPPL-24 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 06/25/2025 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/02/2021 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/05/2020 | SUPPL-20 | REMS-Proposal |
Label is not available on this site. |
||
| 04/01/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/25/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1995 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 04/01/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 07/31/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/26/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 09/02/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1987 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/02/1988 | SUPPL-1 | Bioequivalence |
Label is not available on this site. |
METHADONE HYDROCHLORIDE
TABLET;ORAL; 10MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 211228 | ASCENT PHARMS INC |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 203502 | AUROLIFE PHARMA LLC |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 210484 | ELITE LABS INC |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 090065 | EPIC PHARMA LLC |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 088109 | HIKMA |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 040517 | SPECGX LLC |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 090635 | THEPHARMANETWORK LLC |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 204166 | VISTAPHARM LLC |
TABLET;ORAL; 5MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AA | 211228 | ASCENT PHARMS INC |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AA | 203502 | AUROLIFE PHARMA LLC |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AA | 210484 | ELITE LABS INC |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AA | 090065 | EPIC PHARMA LLC |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AA | 088109 | HIKMA |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AA | 040517 | SPECGX LLC |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AA | 090635 | THEPHARMANETWORK LLC |