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): 018761
Company: BOEHRINGER INGELHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALUPENT | METAPROTERENOL SULFATE | 0.6% | SOLUTION;INHALATION | Discontinued |
None |
No | No |
| ALUPENT | METAPROTERENOL SULFATE | 0.4% | 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 |
|---|---|---|---|---|---|---|---|
| 06/30/1983 | 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 |
|---|---|---|---|---|---|
| 01/23/2002 | SUPPL-16 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18761s16ltr.pdf |
|
| 12/02/1997 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/27/1998 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/22/1990 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/1990 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/22/1987 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/10/1986 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/10/1986 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/10/1986 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/10/1986 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/17/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/02/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/02/1985 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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