Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087092
Company: LANNETT
Company: LANNETT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLTESTOSTERONE | METHYLTESTOSTERONE | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/05/1982 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/087092.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/25/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/11/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/19/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/05/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |