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
ACCUNEB از شرکت MYLAN SPECIALITY LP
New Drug Application (NDA): 020949
Company: MYLAN SPECIALITY LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACCUNEB | ALBUTEROL SULFATE | EQ 0.042% BASE | SOLUTION;INHALATION | Prescription |
AN |
Yes | Yes |
| ACCUNEB | ALBUTEROL SULFATE | EQ 0.021% BASE | SOLUTION;INHALATION | Prescription |
AN |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/30/2001 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-949_AccuNeb.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/30/2013 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/2013 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/2011 | SUPPL-24 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020949s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020949s024ltr.pdf |
||
| 06/02/2006 | SUPPL-11 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020949s011LTR.pdf |
|
| 11/13/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/06/2002 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/20/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/20/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/22/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/22/2002 | 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 |
|---|---|---|---|---|---|
| 03/02/2011 | SUPPL-24 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020949s024lbl.pdf |
ACCUNEB
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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