Drugs@FDA: FDA-Approved Drugs
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VENTOLIN | ALBUTEROL | 0.09MG/INH | AEROSOL, METERED;INHALATION | 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 |
|---|---|---|---|---|---|---|---|
| 05/01/1981 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | PRIORITY |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18473slr030ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/25/2001 | SUPPL-31 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/20/2003 | SUPPL-30 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18473slr030ltr.pdf |
| 08/31/1998 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/30/1998 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 11/12/1997 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 01/26/1995 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/02/1994 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 07/20/1993 | SUPPL-21 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 10/09/1992 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/22/1991 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 04/14/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 09/24/1990 | SUPPL-15 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 07/27/1987 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 07/27/1987 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 11/22/1985 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/20/1985 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/1985 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/22/1985 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/06/1985 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/15/1984 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/21/1983 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/09/1982 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/09/1982 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |