Drugs@FDA: FDA-Approved Drugs
Company: ALVOGEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRANDATE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Discontinued | None | Yes | No |
| TRANDATE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL | Discontinued | None | Yes | No |
| TRANDATE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL | Discontinued | None | Yes | No |
| TRANDATE | LABETALOL HYDROCHLORIDE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 08/01/1984 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/25/2024 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018716s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018716Orig1s036ltr.pdf | |
| 04/27/2016 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018716Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018716Orig1s028ltr.pdf | |
| 10/27/2014 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/2010 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018716s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018716s026ltr.pdf | |
| 02/01/2008 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 04/23/2003 | SUPPL-23 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18716scm023ltr.pdf |
| 08/13/1998 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 04/21/1997 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 06/05/1991 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 05/27/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 02/01/1991 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 06/07/1990 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/07/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/22/1989 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1989 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/16/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/16/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/27/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1987 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/13/1986 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/24/1985 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/24/1985 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/08/1985 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/16/1985 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/26/1985 | SUPPL-1 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/25/2024 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018716s036lbl.pdf | |
| 04/27/2016 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018716Orig1s028lbl.pdf | |
| 11/22/2010 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018716s026lbl.pdf |