Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021103
Company: NOVO NORDISK
Company: NOVO NORDISK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACTIVELLA | ESTRADIOL; NORETHINDRONE ACETATE | 1MG/0.5MG | TABLET; ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 04/11/2000 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21103lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21103ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-103_Activella.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/11/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21103lbl.pdf |