Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061901
Company: APOTHECON
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KANTREX | KANAMYCIN SULFATE | EQ 500MG BASE/2ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| KANTREX | KANAMYCIN SULFATE | EQ 1GM BASE/3ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| KANTREX | KANAMYCIN SULFATE | EQ 75MG BASE/2ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 03/06/1975 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/17/2001 | SUPPL-21 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/02/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1990 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |