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 از شرکت NEPHRON
Abbreviated New Drug Application (ANDA): 076355
Company: NEPHRON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.042% BASE | SOLUTION;INHALATION | Prescription |
AN |
No | No |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.021% BASE | 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 |
|---|---|---|---|---|---|---|---|
| 06/28/2004 | 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 |
|---|---|---|---|---|---|
| 09/13/2011 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/31/2010 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/29/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/22/2005 | SUPPL-1 | Labeling |
Label is not available on this site. |
ALBUTEROL SULFATE
SOLUTION;INHALATION; EQ 0.042% BASE
TE Code = AN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACCUNEB | ALBUTEROL SULFATE | EQ 0.042% BASE | SOLUTION;INHALATION | Prescription | Yes | AN | 020949 | MYLAN SPECIALITY LP |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.042% BASE | SOLUTION;INHALATION | Prescription | No | AN | 076355 | NEPHRON |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.042% BASE | SOLUTION;INHALATION | Prescription | No | AN | 077772 | WATSON LABS |
SOLUTION;INHALATION; EQ 0.021% BASE
TE Code = AN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACCUNEB | ALBUTEROL SULFATE | EQ 0.021% BASE | SOLUTION;INHALATION | Prescription | Yes | AN | 020949 | MYLAN SPECIALITY LP |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.021% BASE | SOLUTION;INHALATION | Prescription | No | AN | 076355 | NEPHRON |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.021% BASE | SOLUTION;INHALATION | Prescription | No | AN | 077772 | WATSON LABS |
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