Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020044
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EXOSURF NEONATAL | CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL | 12MG/VIAL;108MG/VIAL;8MG/VIAL | FOR SUSPENSION;INTRATRACHEAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/02/1990 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/21/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/02/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |