Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050238
Company: BAYER PHARMS
Company: BAYER PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEO-CORT-DOME | ACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATE | 2%;1%;EQ 0.35% BASE | SUSPENSION/DROPS;OTIC | 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 |
|---|---|---|---|---|---|---|---|
| 12/14/1966 | 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 |
|---|---|---|---|---|---|
| 04/06/1982 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/21/1981 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/22/1982 | SUPPL-1 | Labeling |
Label is not available on this site. |