Drugs@FDA: FDA-Approved Drugs
Company: VALIDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOPRESSOR | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | AB | Yes | No |
| LOPRESSOR | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 08/07/1978 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
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-76 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017963Orig1s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/017963Orig1s076Corrected_ltr.pdf | |
| 07/05/2023 | SUPPL-74 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017963s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017963Orig1s074ltr.pdf | |
| 03/21/2016 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/2014 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/2014 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/2013 | SUPPL-68 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017963s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017963Orig1s068ltr.pdf | |
| 12/21/2012 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017963s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017963Orig1s067ltr.pdf | |
| 03/15/2011 | SUPPL-64 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017963s064lbl.pdf | |
| 11/20/2009 | SUPPL-63 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017963s063,018704s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017963s063,018704s023ltr.pdf | |
| 07/24/2008 | SUPPL-62 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017963s062,018704s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017963s062,018704s021ltr.pdf | |
| 01/08/2008 | SUPPL-61 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017963s061,018704s020ltr.pdf |
| 09/05/2006 | SUPPL-59 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018704s018, 017963s059_ltr.pdf |
| 09/12/2003 | SUPPL-58 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18704slr015,17963slr058ltr.pdf |
| 06/14/2002 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/2002 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/2001 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/2000 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1999 | SUPPL-53 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/18/1999 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/1999 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 11/02/1995 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/1995 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/30/1991 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1990 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 10/26/1989 | SUPPL-44 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/03/1989 | SUPPL-43 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/31/1988 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/04/1988 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/1985 | SUPPL-39 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/16/1985 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/30/1985 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/03/1985 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/27/1986 | SUPPL-34 | Efficacy-New Indication |
Label is not available on this site. |
||
| 06/28/1984 | SUPPL-33 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/14/1984 | SUPPL-30 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/12/1983 | SUPPL-28 | Efficacy |
Label is not available on this site. |
||
| 05/17/1983 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/14/1982 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/30/1984 | SUPPL-24 | Efficacy |
Label is not available on this site. |
||
| 03/26/1982 | SUPPL-23 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/03/1981 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/20/1981 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 01/15/1981 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/30/1981 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 09/03/1980 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/17/1980 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/05/1980 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1980 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/27/1981 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/17/1980 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 10/24/1979 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/10/1979 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1979 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/24/1979 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/27/1979 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/07/1979 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/26/1979 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1979 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1979 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/05/1979 | 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-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017963Orig1s076lbl.pdf | |
| 07/05/2023 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017963s074lbl.pdf | |
| 03/14/2013 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017963s068lbl.pdf | |
| 12/21/2012 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017963s067lbl.pdf | |
| 03/15/2011 | SUPPL-64 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017963s064lbl.pdf | |
| 11/20/2009 | SUPPL-63 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017963s063,018704s023lbl.pdf | |
| 07/24/2008 | SUPPL-62 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017963s062,018704s021lbl.pdf |
LOPRESSOR
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LOPRESSOR | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 017963 | VALIDUS PHARMS |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 202871 | ALEMBIC PHARMS LTD |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 077739 | AUROBINDO PHARMA |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 078459 | IPCA LABS LTD |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 076704 | MYLAN |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 074453 | RENATA |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 200981 | RUBICON |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 074644 | SUN PHARM INDS INC |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 208955 | YOUNGTECH PHARMS INC |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LOPRESSOR | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | Yes | AB | 017963 | VALIDUS PHARMS |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | No | AB | 202871 | ALEMBIC PHARMS LTD |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | No | AB | 077739 | AUROBINDO PHARMA |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | No | AB | 078459 | IPCA LABS LTD |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | No | AB | 076704 | MYLAN |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | No | AB | 074453 | RENATA |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | No | AB | 200981 | RUBICON |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | No | AB | 074644 | SUN PHARM INDS INC |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | No | AB | 208955 | YOUNGTECH PHARMS INC |