Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205187
Company: MICRO LABS LTD INDIA
Company: MICRO LABS LTD INDIA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION;ORAL | Discontinued | None | No | No |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 05/21/2021 | 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 |
|---|---|---|---|---|---|
| 05/01/2024 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/16/2024 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |