Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084476
Company: BAYER PHARMS
Company: BAYER PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOMEBORO | ACETIC ACID, GLACIAL; ALUMINUM ACETATE | 2%;0.79% | SOLUTION/DROPS;OTIC | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 04/30/1976 | 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 |
|---|---|---|---|---|---|
| 02/24/1994 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/29/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |