Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075441
Company: APOTEX INC
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IPRATROPIUM BROMIDE | IPRATROPIUM BROMIDE | 0.02% | 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 |
|---|---|---|---|---|---|---|---|
| 03/28/2001 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75441ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-441_Ipratropium%20Bromide.pdf |