Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040312
Company: NOVO NORDISK INC
Company: NOVO NORDISK INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INNOFEM | ESTRADIOL | 0.5MG | TABLET;ORAL | Discontinued | None | No | No |
| INNOFEM | ESTRADIOL | 1MG | TABLET;ORAL | Discontinued | None | No | No |
| INNOFEM | ESTRADIOL | 2MG | TABLET;ORAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 11/19/1999 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40312ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/40312_Innofem.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/15/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/17/2001 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |