COMPANY
Accord Healthcare, Inc.
Accord Healthcare, Inc.: marketing authorisation holder, US labeler, recalling firm for Daptomycin, Icatibant, Leuprolide, as stated by public registers.
Also written as: ACCORD HEALTHCARE INC; Accord Healthcare Inc..
MARKETING AUTHORISATION HOLDER
Holds the licence to sell the medicine in a country (EMA, MHRA, Health Canada).
| Daptomycin | DAPTOMYCIN FOR INJECTION (DIN 02494590), Cancelled Post Market Regulator Health Canada |
|---|---|
| Icatibant | ICATIBANT INJECTION (DIN 02516608), Cancelled Pre Market Regulator Health Canada |
| Leuprolide | CAMCEVI (DIN 02522446), Approved Regulator Health Canada |
| Leuprolide | CAMCEVI (DIN 02567148), Approved Regulator Health Canada |
US LABELER
Lists a finished product with FDA (NDC directory); can be a maker, repackager or distributor.
| Daptomycin | Daptomycin, ANDA Regulator openFDA |
|---|---|
| Daptomycin | DAPTOMYCIN, ANDA Regulator openFDA |
RECALLING FIRM
Recalled a product naming the peptide (FDA enforcement report).
| Daptomycin | Class I recall, Terminated, 2023-01-25 Regulator openFDA |
|---|---|
| Daptomycin | Class II recall, Terminated, 2023-03-08 Regulator openFDA |
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