Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019112
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VENTOLIN | ALBUTEROL SULFATE | EQ 2MG BASE | TABLET;ORAL | Discontinued | None | No | No |
VENTOLIN | ALBUTEROL SULFATE | EQ 4MG BASE | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
07/10/1986 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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-14 | Labeling |
Label is not available on this site. |
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10/30/1997 | SUPPL-13 | Labeling |
Label is not available on this site. |
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01/26/1995 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/13/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
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01/28/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
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05/25/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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05/10/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
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12/04/1996 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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12/09/1987 | SUPPL-2 | Labeling |
Label is not available on this site. |
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06/02/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |