Drugs@FDA: FDA-Approved Drugs
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEBCIN | TOBRAMYCIN SULFATE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 06/11/1975 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/02/2003 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50477slr024,50519slr024ltr.pdf |
| 03/04/1999 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 10/01/1997 | SUPPL-21 | Efficacy-New Patient Population |
Label is not available on this site. |
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| 04/03/1997 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/18/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/19/1997 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 05/13/1997 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 04/01/1993 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 08/06/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 05/28/1980 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 06/02/1976 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 02/23/1976 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 01/13/1976 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 09/03/1975 | SUPPL-10 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
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| 07/30/1975 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 10/28/1991 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/28/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 07/21/1987 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 04/02/1987 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 03/05/1987 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/04/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 09/28/1984 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/24/1984 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |