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): 017659
Company: BOEHRINGER INGELHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALUPENT | METAPROTERENOL SULFATE | 5% | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 09/18/1980 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 05/01/1997 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/13/1997 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/1996 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/02/1992 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/02/1992 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 11/14/1991 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 11/14/1991 | SUPPL-25 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 10/29/1986 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 04/12/1988 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/14/1986 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/19/1985 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/30/1983 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 03/03/1983 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/05/1982 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/05/1983 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/30/1982 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/22/1982 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/22/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1982 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/11/1981 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/12/1981 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 07/10/1981 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/03/1981 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/18/1981 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 01/16/1981 | SUPPL-1 | Labeling |
Label is not available on this site. |
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