Drugs@FDA: FDA-Approved Drugs
Company: VISTAPHARM LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | 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 |
---|---|---|---|---|---|---|---|
05/29/1998 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40241ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40241ap.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/15/2023 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
09/18/2018 | SUPPL-19 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
05/26/2017 | SUPPL-18 | REMS-Modified |
Label is not available on this site. |
||
09/30/2016 | SUPPL-16 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
10/31/2016 | SUPPL-15 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
04/20/2016 | SUPPL-14 | REMS-Modified |
Label is not available on this site. |
||
05/29/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
06/26/2015 | SUPPL-12 | REMS-Modified |
Label is not available on this site. |
||
08/19/2014 | SUPPL-11 | REMS-Modified |
Label is not available on this site. |
||
12/19/2014 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
04/15/2013 | SUPPL-8 | REMS-Modified |
Label is not available on this site. |
||
07/09/2012 | SUPPL-7 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
07/09/2012 | SUPPL-6 | REMS-Proposal |
Label is not available on this site. |
||
02/05/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
02/02/2000 | SUPPL-1 | Manufacturing (CMC)-Facility |
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 | 090065 | EPIC PHARMA LLC |
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 088109 | ROXANE |
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 | 040241 | VISTAPHARM LLC |
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 204166 | VISTAPHARM LLC |