Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 006134
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOLOPHINE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| DOLOPHINE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG/30ML | SYRUP;ORAL | Discontinued | None | No | No |
| DOLOPHINE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 08/13/1947 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/02/2021 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/006134s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/006134Orig1s050ltr.pdf | |
| 10/07/2019 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/006134s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/006134Orig1s049ltr.pdf | |
| 09/18/2018 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s046s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/006134Orig1s046s048ltr.pdf | |
| 09/18/2018 | SUPPL-46 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s046s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/006134Orig1s046s048ltr.pdf | |
| 02/01/2018 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/006134Orig1s045ltr.pdf | |
| 05/26/2017 | SUPPL-44 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/006134Orig1s044ltr.pdf |
| 09/30/2016 | SUPPL-42 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006134Orig1s042ltr.pdf |
| 12/16/2016 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006134s040s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006134Orig1s040,s041ltr.pdf | |
| 12/16/2016 | SUPPL-40 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006134s040s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006134Orig1s040,s041ltr.pdf | |
| 04/20/2016 | SUPPL-39 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006134Orig1s039ltr.pdf |
| 04/02/2015 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/006134s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/006134Orig1s038ltr.pdf | |
| 06/26/2015 | SUPPL-37 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/006134Orig1s037ltr.pdf |
| 08/19/2014 | SUPPL-36 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/006134Orig1s036ltr.pdf |
| 04/16/2014 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/006134s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/006134Orig1s035ltr.pdf | |
| 04/15/2013 | SUPPL-32 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/006134Orig1s032ltr.pdf |
| 07/09/2012 | SUPPL-31 | REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/006134s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/006134Orig1s031ltr.pdf | |
| 07/09/2012 | SUPPL-30 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/006134Orig1s030ltr.pdf |
| 11/17/2006 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/006134s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/06134s028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/006134_s028_dolophine_hydrochloride.pdf | |
| 05/05/2000 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/30/1999 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/12/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/15/1996 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/2000 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 02/21/1995 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1994 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/12/1999 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 08/13/1987 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 01/10/1986 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 10/16/1981 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1980 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/05/1977 | SUPPL-8 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/02/2021 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/006134s050lbl.pdf | |
| 10/07/2019 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/006134s049lbl.pdf | |
| 09/18/2018 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s046s048lbl.pdf | |
| 09/18/2018 | SUPPL-46 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s046s048lbl.pdf | |
| 02/01/2018 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s045lbl.pdf | |
| 12/16/2016 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006134s040s041lbl.pdf | |
| 12/16/2016 | SUPPL-40 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006134s040s041lbl.pdf | |
| 12/16/2016 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006134s040s041lbl.pdf | |
| 12/16/2016 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006134s040s041lbl.pdf | |
| 04/02/2015 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/006134s038lbl.pdf | |
| 04/16/2014 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/006134s035lbl.pdf | |
| 07/09/2012 | SUPPL-31 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/006134s031lbl.pdf | |
| 11/17/2006 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/006134s028lbl.pdf |