Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021320
Company: SPECIALITY EUROPEAN
Company: SPECIALITY EUROPEAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PLENAXIS | ABARELIX | 100MG/VIAL | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/08/2005 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021320s002lbl.pdf | |
| 11/25/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21320_plenaxis_lbl.pdf |
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