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
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE از شرکت CIPLA
Abbreviated New Drug Application (ANDA): 077559
Company: CIPLA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | ALBUTEROL SULFATE; IPRATROPIUM BROMIDE | EQ 0.083% BASE;0.017% | SOLUTION;INHALATION | Prescription |
AN |
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 |
|---|---|---|---|---|---|---|---|
| 12/31/2007 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/24/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2013 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
SOLUTION;INHALATION; EQ 0.083% BASE;0.017%
TE Code = AN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | ALBUTEROL SULFATE; IPRATROPIUM BROMIDE | EQ 0.083% BASE;0.017% | SOLUTION;INHALATION | Prescription | No | AN | 077559 | CIPLA |
| ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | ALBUTEROL SULFATE; IPRATROPIUM BROMIDE | EQ 0.083% BASE;0.017% | SOLUTION;INHALATION | Prescription | No | AN | 076749 | NEPHRON |
| ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | ALBUTEROL SULFATE; IPRATROPIUM BROMIDE | EQ 0.083% BASE;0.017% | SOLUTION;INHALATION | Prescription | No | AN | 202496 | RITEDOSE CORP |
| ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | ALBUTEROL SULFATE; IPRATROPIUM BROMIDE | EQ 0.083% BASE;0.017% | SOLUTION;INHALATION | Prescription | No | AN | 207875 | SUN PHARM |
منبع : www.accessdata.fda.gov
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