Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078623
Company: APOTEX INC
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.021% BASE | SOLUTION;INHALATION | Discontinued | None | No | No |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.042% BASE | SOLUTION;INHALATION | 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 |
|---|---|---|---|---|---|---|---|
| 04/05/2010 | 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 |
|---|---|---|---|---|---|
| 02/02/2023 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/28/2014 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |