اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
ALUPENT از شرکت BOEHRINGER INGELHEIM
New Drug Application (NDA): 016402
Company: BOEHRINGER INGELHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALUPENT | METAPROTERENOL SULFATE | 0.65MG/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 |
|---|---|---|---|---|---|---|---|
| 07/31/1973 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/26/1997 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1997 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 07/08/1994 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 12/07/1989 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/17/1989 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/17/1989 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 03/17/1989 | SUPPL-28 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/24/1986 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 10/09/1986 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/04/1986 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 11/29/1985 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 05/17/1985 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/21/1984 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/16/1984 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 08/16/1984 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1982 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/01/1982 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/24/1981 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/04/1980 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/01/1979 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/13/1978 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1978 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 05/25/1977 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/22/1976 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1976 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1976 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/18/1974 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/18/1974 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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