Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202590
Company: AVET LIFESCIENCES
Company: AVET LIFESCIENCES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVOFLOXACIN | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
LEVOFLOXACIN | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE;INJECTION | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
01/24/2013 | 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 |
---|---|---|---|---|---|
01/11/2024 | SUPPL-11 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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05/03/2019 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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10/18/2018 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/17/2019 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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07/14/2016 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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07/14/2016 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |