Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200674
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 750MG/150ML (EQ 5MG/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 |
---|---|---|---|---|---|---|---|
06/19/2013 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/03/2019 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/18/2018 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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04/24/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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10/19/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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10/19/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; EQ 250MG/50ML (EQ 5MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091397 | BAXTER HLTHCARE CORP |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 200674 | FRESENIUS KABI USA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 206908 | GLAND PHARMA LTD |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091375 | HIKMA FARMACEUTICA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078579 | HOSPIRA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090343 | INFORLIFE |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 216164 | KNACK |
INJECTABLE;INJECTION; EQ 500MG/100ML (EQ 5MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091397 | BAXTER HLTHCARE CORP |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 200674 | FRESENIUS KABI USA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 206908 | GLAND PHARMA LTD |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091375 | HIKMA FARMACEUTICA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078579 | HOSPIRA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090343 | INFORLIFE |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 216164 | KNACK |
INJECTABLE;INJECTION; EQ 750MG/150ML (EQ 5MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091397 | BAXTER HLTHCARE CORP |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 200674 | FRESENIUS KABI USA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 206908 | GLAND PHARMA LTD |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091375 | HIKMA FARMACEUTICA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078579 | HOSPIRA |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090343 | INFORLIFE |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 216164 | KNACK |