Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019773
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VENTOLIN | ALBUTEROL SULFATE | EQ 0.083% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INHALATION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 04/23/1992 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 09/18/1998 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 10/30/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 06/16/1997 | SUPPL-8 | Efficacy-New Indication |
Label is not available on this site. |
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| 01/26/1995 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/21/1994 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 11/10/1993 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/13/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |