Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061716
Company: SCHERING
Company: SCHERING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GARAMYCIN | GENTAMICIN SULFATE | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |
GARAMYCIN | GENTAMICIN SULFATE | EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
03/03/1981 | 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 |
---|---|---|---|---|---|
01/04/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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09/08/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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11/29/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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02/14/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |