Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018153
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BECLOVENT | BECLOMETHASONE DIPROPIONATE | 0.042MG/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 |
|---|---|---|---|---|---|---|---|
| 06/24/1980 | 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 |
|---|---|---|---|---|---|
| 12/10/1997 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 07/06/1993 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 08/10/1992 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1993 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 12/15/1988 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 04/27/1989 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/1987 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/10/1985 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 09/10/1985 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/13/1985 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 09/15/1984 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/01/1984 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/01/1984 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/15/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 02/16/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 02/16/1988 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/19/1982 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 01/19/1982 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |