Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205833
Company: MYLAN LABS LTD
Company: MYLAN LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER | MOXIFLOXACIN HYDROCHLORIDE | 400MG/250ML (1.6MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 05/05/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/19/2023 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/04/2019 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/30/2019 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/03/2019 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/18/2018 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |