Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075835
Company: BAUSCH
Company: BAUSCH
| 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 |
|---|---|---|---|---|---|---|---|
| 10/15/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75835.ap..pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/02/2002 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/18/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |