Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091678
Company: NOVITIUM PHARMA
Company: NOVITIUM PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVOFLOXACIN | LEVOFLOXACIN | 250MG/10ML | SOLUTION;ORAL | Prescription | AA | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/20/2011 | 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 |
---|---|---|---|---|---|
05/23/2019 | SUPPL-6 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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10/18/2018 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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05/22/2019 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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02/11/2015 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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03/08/2013 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/05/2011 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
LEVOFLOXACIN
SOLUTION;ORAL; 250MG/10ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LEVOFLOXACIN | LEVOFLOXACIN | 250MG/10ML | SOLUTION;ORAL | Prescription | No | AA | 205222 | LANNETT CO INC |
LEVOFLOXACIN | LEVOFLOXACIN | 250MG/10ML | SOLUTION;ORAL | Prescription | No | AA | 091678 | NOVITIUM PHARMA |