Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040138
Company: LANNETT CO INC
Company: LANNETT CO INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ESTRADIOL | ESTRADIOL | 0.5MG | TABLET;ORAL | Discontinued | None | No | No |
| ESTRADIOL | ESTRADIOL | 1MG | TABLET;ORAL | Discontinued | None | No | No |
| ESTRADIOL | 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 |
|---|---|---|---|---|---|---|---|
| 01/30/1998 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040138ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/08/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/21/2000 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/21/2000 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |