Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050544
Company: SCHERING
Company: SCHERING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NETROMYCIN | NETILMICIN SULFATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| NETROMYCIN | NETILMICIN SULFATE | EQ 25MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| NETROMYCIN | NETILMICIN SULFATE | EQ 100MG BASE/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 02/28/1983 | 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 |
|---|---|---|---|---|---|
| 01/13/1998 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/17/1997 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/01/1997 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/20/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/22/1994 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/14/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/15/1987 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 03/12/1986 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/12/1984 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/11/1984 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/17/1983 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/18/1984 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 03/28/1983 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |