Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 10MG 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 |
---|---|---|---|---|---|---|---|
06/05/1980 | 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 |
---|---|---|---|---|---|
02/15/2022 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
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07/23/2001 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/23/2001 | SUPPL-27 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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07/23/2001 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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10/14/1999 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/11/1999 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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02/03/1994 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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09/16/1993 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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11/18/1991 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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05/17/1991 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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05/31/1991 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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02/08/1991 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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11/19/1990 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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07/12/1988 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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02/22/1988 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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05/22/1987 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
GENTAMICIN SULFATE
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 |
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 |