Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019998
Company: RECORDATI RARE
Company: RECORDATI RARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CHEMET | SUCCIMER | 100MG | CAPSULE;ORAL | Prescription | None | Yes | Yes |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/02/2018 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019998s021lbl.pdf | |
07/11/2007 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019998s013lbl.pdf |