Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018303
Company: VALIDUS PHARMS
Company: VALIDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOPRESSOR HCT | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE | 25MG;50MG | TABLET;ORAL | Prescription | AB | Yes | No |
| LOPRESSOR HCT | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE | 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| LOPRESSOR HCT | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE | 50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/31/1984 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
|---|---|---|---|---|---|
| 12/22/2023 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018303s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018303Orig1s042ltr.pdf | |
| 08/20/2020 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018303s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018303Orig1s041ltr.pdf | |
| 05/03/2022 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018303s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018303Orig1s040ltr.pdf | |
| 03/15/2011 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018303s035s036lbl.pdf | |
| 03/15/2011 | SUPPL-35 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018303s035s036lbl.pdf | |
| 08/07/2009 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018303s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018303s034ltr.pdf | |
| 07/24/2008 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018303s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018303s033ltr.pdf | |
| 01/08/2008 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018303s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018303s032ltr.pdf | |
| 09/07/2006 | SUPPL-29 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018303s029_ltr.pdf |
| 10/31/2003 | SUPPL-25 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18303slr025ltr.pdf |
| 06/14/2002 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/2002 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/2002 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/30/2001 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/2000 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/2000 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/28/1999 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/18/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/1997 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 01/08/1997 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/07/1996 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/04/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1995 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/02/1995 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 11/08/1991 | SUPPL-10 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/18/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 06/14/1990 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/09/1988 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/23/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 05/31/1988 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/23/1985 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/22/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/26/1985 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/22/2023 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018303s042lbl.pdf | |
| 05/03/2022 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018303s040lbl.pdf | |
| 08/20/2020 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018303s041lbl.pdf | |
| 03/15/2011 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018303s035s036lbl.pdf | |
| 03/15/2011 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018303s035s036lbl.pdf | |
| 08/07/2009 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018303s034lbl.pdf | |
| 07/24/2008 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018303s033lbl.pdf | |
| 01/08/2008 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018303s032lbl.pdf |
LOPRESSOR HCT
TABLET;ORAL; 25MG;50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LOPRESSOR HCT | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE | 25MG;50MG | TABLET;ORAL | Prescription | Yes | AB | 018303 | VALIDUS PHARMS |
| METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE | 25MG;50MG | TABLET;ORAL | Prescription | No | AB | 202870 | ALEMBIC |
| METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE | 25MG;50MG | TABLET;ORAL | Prescription | No | AB | 076792 | MYLAN |
| METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE | 25MG;50MG | TABLET;ORAL | Prescription | No | AB | 090654 | SUN PHARM INDS |