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
COMBIVENT از شرکت BOEHRINGER INGELHEIM
New Drug Application (NDA): 020291
Company: BOEHRINGER INGELHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COMBIVENT | ALBUTEROL SULFATE; IPRATROPIUM BROMIDE | EQ 0.09MG BASE/INH;0.018MG/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 |
|---|---|---|---|---|---|---|---|
| 10/24/1996 | ORIG-1 | Approval |
Type 4 – New Combination |
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 |
|---|---|---|---|---|---|
| 08/20/2012 | SUPPL-31 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020291s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020291Orig1s031ltr.pdf |
||
| 09/17/2012 | SUPPL-30 | Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020291Orig1s030ltr.pdf |
|
| 04/01/2011 | SUPPL-29 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020291s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020291s029ltr.pdf |
||
| 06/02/2009 | SUPPL-27 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020291s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020291s027ltr.pdf |
||
| 05/07/2009 | SUPPL-26 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020291s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020291s026ltr.pdf |
||
| 11/10/2008 | SUPPL-23 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020291s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020291s023ltr.pdf |
||
| 06/01/2006 | SUPPL-20 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020291s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020291s020LTR.pdf |
||
| 07/23/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/16/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1999 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/22/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1998 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/23/1999 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/26/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/14/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/1997 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/20/2012 | SUPPL-31 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020291s031lbl.pdf | |
| 04/01/2011 | SUPPL-29 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020291s029lbl.pdf | |
| 06/02/2009 | SUPPL-27 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020291s027lbl.pdf | |
| 05/07/2009 | SUPPL-26 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020291s026lbl.pdf | |
| 11/10/2008 | SUPPL-23 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020291s023lbl.pdf | |
| 06/01/2006 | SUPPL-20 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020291s020lbl.pdf |
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