Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050237
Company: BAYER PHARMS
Company: BAYER PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NEO-CORT-DOME | HYDROCORTISONE; NEOMYCIN SULFATE | 1%;EQ 3.5MG BASE/GM | CREAM;TOPICAL | Discontinued | None | No | No |
NEO-CORT-DOME | HYDROCORTISONE; NEOMYCIN SULFATE | 0.5%;EQ 3.5MG BASE/GM | CREAM;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
10/19/1964 | 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 |
---|---|---|---|---|---|
03/21/1980 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/19/1985 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/05/1984 | SUPPL-2 | Labeling |
Label is not available on this site. |
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07/05/1983 | SUPPL-1 | Labeling |
Label is not available on this site. |