Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050404
Company: LEDERLE
Company: LEDERLE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AUREOMYCIN | CHLORTETRACYCLINE HYDROCHLORIDE | 1% | OINTMENT;OPHTHALMIC | 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 |
|---|---|---|---|---|---|---|---|
| 01/23/1950 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/13/1975 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/07/1974 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/08/1974 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/20/1973 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/10/1973 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/15/1969 | SUPPL-14 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/01/1963 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 04/06/1961 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/18/1959 | SUPPL-11 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/09/1959 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/01/1958 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/11/1952 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/02/1951 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/07/1950 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/01/1988 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/23/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1950 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/26/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |