Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050549
Company: BAYER PHARMS
Company: BAYER PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEZLIN | MEZLOCILLIN SODIUM MONOHYDRATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MEZLIN | MEZLOCILLIN SODIUM MONOHYDRATE | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MEZLIN | MEZLOCILLIN SODIUM MONOHYDRATE | EQ 3GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MEZLIN | MEZLOCILLIN SODIUM MONOHYDRATE | EQ 4GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MEZLIN | MEZLOCILLIN SODIUM MONOHYDRATE | EQ 20GM BASE/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 09/21/1981 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 11/10/1998 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/05/1997 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 12/26/1996 | SUPPL-20 | Labeling |
Label is not available on this site. |