Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018704
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOPRESSOR METOPROLOL TARTRATE 1MG/ML 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

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