Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 063117
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOBRAMYCIN SULFATE | TOBRAMYCIN 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 |
---|---|---|---|---|---|---|---|
04/26/1991 | 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 |
---|---|---|---|---|---|
01/17/2023 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
02/26/2002 | SUPPL-8 | Labeling |
Label is not available on this site. |
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07/23/2001 | SUPPL-7 | Labeling |
Label is not available on this site. |
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08/30/2000 | SUPPL-6 | Labeling |
Label is not available on this site. |
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04/25/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
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09/13/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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07/28/1994 | SUPPL-3 | Labeling |
Label is not available on this site. |
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08/17/1994 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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04/27/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |
TOBRAMYCIN 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 |
---|---|---|---|---|---|---|---|---|
TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206965 | BAXTER HLTHCARE CORP |
TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065122 | FRESENIUS KABI USA |
TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209621 | GLAND PHARMA LTD |
TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 063117 | HIKMA |
TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 063111 | HOSPIRA |
TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065407 | MYLAN LABS LTD |
TOBRAMYCIN SULFATE (PHARMACY BULK) | TOBRAMYCIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065120 | FRESENIUS KABI USA |
TOBRAMYCIN SULFATE (PHARMACY BULK) | TOBRAMYCIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209346 | GLAND PHARMA LTD |