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 MYLAN SPECLT
Abbreviated New Drug Application (ANDA): 072652
Company: MYLAN SPECLT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.083% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION;INHALATION | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 02/21/1992 | 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 |
|---|---|---|---|---|---|
| 12/08/2011 | SUPPL-47 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 02/16/2012 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/26/2004 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 04/01/2004 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 12/09/2002 | SUPPL-21 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 12/09/2002 | SUPPL-19 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/31/2001 | SUPPL-18 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 12/20/2000 | SUPPL-17 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 11/17/1999 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/23/2000 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/29/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/14/1999 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/08/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/24/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/30/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 05/04/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/30/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/22/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |
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