Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091532
Company: SAMSON MEDCL
Company: SAMSON MEDCL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER | VANCOMYCIN HYDROCHLORIDE | EQ 100GM BASE | POWDER;INTRAVENOUS | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 01/06/2016 | 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 |
|---|---|---|---|---|---|
| 08/13/2020 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/21/2018 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |