Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209911
Company: MYLAN LABS LTD
Company: MYLAN LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 2GM/50ML (40MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 4GM/100ML (40MG/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 |
|---|---|---|---|---|---|---|---|
| 09/14/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |