Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 005378
Company: AJENAT PHARMS
Company: AJENAT PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DESOXYN | METHAMPHETAMINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | AA | Yes | Yes |
| DESOXYN | METHAMPHETAMINE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| DESOXYN | METHAMPHETAMINE HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| DESOXYN | METHAMPHETAMINE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 12/31/1943 | 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 |
|---|---|---|---|---|---|
| 10/13/2023 | SUPPL-38 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/005378s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/005378Orig1s038ltr.pdf | |
| 02/25/2022 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/005378s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/005378Orig1s037ltr.pdf | |
| 04/11/2019 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/005378s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/005378Orig1s035ltr.pdf | |
| 05/19/2017 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005378s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/005378Orig1s034ltr.pdf | |
| 09/24/2024 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/005378s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/005378Orig1s032ltr.pdf | |
| 01/04/2017 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005378s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/005378Orig1s031ltr.pdf | |
| 04/17/2015 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/005378s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/005378Orig1s030ltr.pdf | |
| 01/26/2015 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/2013 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/005378s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/005378Orig1s028ltr.pdf | |
| 08/23/2013 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/0005378s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/005378Orig1s027ltr.pdf | |
| 05/11/2007 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/005378s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/005378s026ltr.pdf | |
| 04/12/2006 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/005378s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/05378s024ltr.pdf | |
| 11/20/2000 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1999 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/13/1998 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/06/2001 | SUPPL-20 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/05378s20ltr.pdf | |
| 07/27/1989 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1983 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/27/1983 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 09/22/1982 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1984 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/30/1981 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1979 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/22/1975 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/22/1975 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/22/1975 | SUPPL-3 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/24/2024 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/005378s032lbl.pdf | |
| 10/13/2023 | SUPPL-38 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/005378s038lbl.pdf | |
| 10/13/2023 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/005378s038lbl.pdf | |
| 02/25/2022 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/005378s037lbl.pdf | |
| 04/11/2019 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/005378s035lbl.pdf | |
| 05/19/2017 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005378s034lbl.pdf | |
| 01/04/2017 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005378s031lbl.pdf | |
| 04/17/2015 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/005378s030lbl.pdf | |
| 12/03/2013 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/005378s028lbl.pdf | |
| 08/23/2013 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/0005378s027lbl.pdf | |
| 05/11/2007 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/005378s026lbl.pdf | |
| 04/12/2006 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/005378s024lbl.pdf | |
| 12/06/2001 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/05378s20ltr.pdf |
DESOXYN
TABLET;ORAL; 5MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DESOXYN | METHAMPHETAMINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | Yes | AA | 005378 | AJENAT PHARMS |
| METHAMPHETAMINE HYDROCHLORIDE | METHAMPHETAMINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AA | 091189 | DR REDDYS LABS SA |
| METHAMPHETAMINE HYDROCHLORIDE | METHAMPHETAMINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AA | 203846 | HIKMA |