Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020937
Company: LIEBEL-FLARSHEIM
Company: LIEBEL-FLARSHEIM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OPTIMARK | GADOVERSETAMIDE | 1654.5MG/5ML (330.9MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
OPTIMARK | GADOVERSETAMIDE | 3309MG/10ML (330.9MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
OPTIMARK | GADOVERSETAMIDE | 4963.5MG/15ML (330.9MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
OPTIMARK | GADOVERSETAMIDE | 6618MG/20ML (330.9MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/02/2018 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s028,020975s029,020976s030lbl.pdf | |
04/26/2018 | SUPPL-27 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s027lbl.pdf | |
04/26/2018 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s027lbl.pdf | |
08/29/2016 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020937s026,020975s027,020976s028lbl.pdf | |
11/24/2014 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/2014/020937s02420975s2520976s26lbl.pdf | |
08/07/2014 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020937s023,020975s024,020976s025lbl.pdf | |
08/26/2013 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020937s022lbl.pdf | |
05/21/2013 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020937s021,020975s022,020976s022lbl.pdf | |
12/20/2010 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020937s016lbl.pdf | |
09/04/2007 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020937s011,020976s011,020975s012lbl.pdf | |
08/04/2006 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020937,020975,020976s009lbl.pdf | |
01/31/2003 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937S003_OptiMark_Prntlbl.pdf | |
12/08/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark_prntlbl.pdf |