Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050505
Company: SCHERING
Company: SCHERING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GARAMYCIN | GENTAMICIN SULFATE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INTRATHECAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
10/01/1979 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
10/21/1980 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
03/18/1980 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
02/14/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/20/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/17/1986 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
10/17/1983 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
05/17/1983 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
10/29/1982 | SUPPL-1 | Labeling |
Label is not available on this site. |