Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050682
Company: RECORDATI RARE
Company: RECORDATI RARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COSMEGEN | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/15/2018 | SUPPL-34 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050682s034lbl.pdf | |
| 08/15/2018 | SUPPL-33 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050682s033lbl.pdf | |
| 02/03/2012 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050682s029s030lbl.pdf | |
| 02/03/2012 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050682s029s030lbl.pdf | |
| 03/13/2009 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050682s025lbl.pdf |
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