Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021484
Company: FERRING
Company: FERRING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BRAVELLE | UROFOLLITROPIN | 0.9% | Injectable; Subcutaneous | Prescription | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/19/2002 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21484_Bravelle_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-484_Bravelle_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021484_bravelle.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/19/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21484_Bravelle_lbl.pdf |