Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
08/15/1983 | 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 |
---|---|---|---|---|---|
02/10/2023 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
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02/01/2023 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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04/21/2004 | SUPPL-14 | Labeling |
Label is not available on this site. |
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10/25/2002 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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03/22/2001 | SUPPL-12 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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03/22/2001 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/07/2000 | SUPPL-10 | Labeling |
Label is not available on this site. |
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01/07/2000 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
09/18/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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12/09/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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10/03/1996 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
10/22/1996 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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10/04/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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07/13/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |
GENTAMICIN SULFATE
INJECTABLE;INJECTION; EQ 10MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215236 | EUGIA PHARMA |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062366 | FRESENIUS KABI USA |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062251 | HIKMA |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062420 | HOSPIRA |
INJECTABLE;INJECTION; EQ 40MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215237 | EUGIA PHARMA |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062366 | FRESENIUS KABI USA |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062251 | HIKMA |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062420 | HOSPIRA |