Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021878
Company: NOVO NORDISK
Company: NOVO NORDISK
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVEMIR | INSULIN DETEMIR | 100 UNITS/ML | INJECTABLE; INJECTION | 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 |
---|---|---|---|---|---|---|---|
10/19/2005 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021878lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021878ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021878s000_LevemirTOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/19/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021878lbl.pdf |