Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018704
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOPRESSOR | METOPROLOL TARTRATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 03/30/1984 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 08/24/2020 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018704s027,028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018704Orig1s027, s028ltr.pdf | |
| 08/24/2020 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018704s027,028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018704Orig1s027, s028ltr.pdf | |
| 03/14/2013 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018704s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018704Orig1s026ltr.pdf | |
| 12/21/2012 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018704s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018704Orig1s025ltr.pdf | |
| 11/20/2009 | SUPPL-23 | 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-21 | 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-20 | 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-18 | 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-15 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18704slr015,17963slr058ltr.pdf |
| 04/29/2002 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/15/2002 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/2001 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/1996 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/19/1995 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/14/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/04/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/1985 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/20/1984 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/24/2020 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018704s027,028lbl.pdf | |
| 08/24/2020 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018704s027,028lbl.pdf | |
| 03/14/2013 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018704s026lbl.pdf | |
| 12/21/2012 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018704s025lbl.pdf | |
| 11/20/2009 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017963s063,018704s023lbl.pdf | |
| 07/24/2008 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017963s062,018704s021lbl.pdf |