ANDA 62814, held by B Braun. Gentamicin Sulfate.
As of Nov 15, 2026, ANDA 62814 (Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container), held by B Braun, was first approved by FDA on Aug 28, 1987, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 1987 | Original application | Approved | None posted |
| Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 0.8MG BASE/ML · injectable;injection | Gentamicin Sulfate | Discontinued |
| Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 1.2MG BASE/ML · injectable;injection | Gentamicin Sulfate | Discontinued |
| Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 1.4MG BASE/ML · injectable;injection | Gentamicin Sulfate | Discontinued |
| Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 1.6MG BASE/ML · injectable;injection | Gentamicin Sulfate | Discontinued |
| Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 1.8MG BASE/ML · injectable;injection | Gentamicin Sulfate | Discontinued |
| Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 2MG BASE/ML · injectable;injection | Gentamicin Sulfate | Discontinued |
| Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 2.4MG BASE/ML · injectable;injection | Gentamicin Sulfate | Discontinued |
| Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 40MG BASE/100ML · injectable;injection | Gentamicin Sulfate | Discontinued |
| Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 60MG BASE/100ML · injectable;injection | Gentamicin Sulfate | Discontinued |
| Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 70MG BASE/100ML · injectable;injection | Gentamicin Sulfate | Discontinued |
| Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 80MG BASE/100ML · injectable;injection | Gentamicin Sulfate | Discontinued |
| Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 90MG BASE/100ML · injectable;injection | Gentamicin Sulfate | Discontinued |
| Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 100MG BASE/100ML · injectable;injection | Gentamicin Sulfate | Discontinued |
| Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic ContainerEQ 120MG BASE/100ML · injectable;injection | Gentamicin Sulfate | Discontinued |
| May 13, 2010 | Supplement 21Labeling | Approved | None posted |
| Nov 30, 2009 | Supplement 18Labeling | Approved | None posted |
| Nov 20, 2008 | Supplement 17Labeling | Approved | None posted |
| Sep 12, 2007 | Supplement 16Labeling | Approved | None posted |
| Dec 7, 2006 | Supplement 15Labeling | Approved | None posted |
| Jun 7, 2005 | Supplement 13Labeling | Approved | None posted |
| Aug 31, 2004 | Supplement 12Labeling | Approved | None posted |
| Aug 21, 2001 | Supplement 10Manufacturing | Approved | None posted |
| Aug 3, 2001 | Supplement 9Manufacturing | Approved | None posted |
| May 16, 1997 | Supplement 8Manufacturing | Approved | None posted |
| Mar 1, 1996 | Supplement 7Manufacturing | Approved | None posted |
| Nov 18, 1992 | Supplement 5Labeling | Approved | None posted |
| Jan 29, 1992 | Supplement 4Manufacturing | Approved | None posted |
| Aug 28, 1987 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
