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): 074880
Company: NEPHRON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.083% BASE | SOLUTION;INHALATION | Prescription |
AN |
No | 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 |
|---|---|---|---|---|---|---|---|
| 09/17/1997 | 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 |
|---|---|---|---|---|---|
| 03/28/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/06/2001 | SUPPL-11 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 06/06/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/17/2000 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/17/2000 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/29/1999 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/21/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/26/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 11/20/1997 | SUPPL-1 | Labeling |
Label is not available on this site. |
ALBUTEROL SULFATE
SOLUTION;INHALATION; EQ 0.083% BASE
TE Code = AN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.083% BASE | SOLUTION;INHALATION | Prescription | No | AN | 206224 | AUROBINDO PHARMA LTD |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.083% BASE | SOLUTION;INHALATION | Prescription | No | AN | 074880 | NEPHRON |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.083% BASE | SOLUTION;INHALATION | Prescription | No | AN | 077839 | RITEDOSE CORP |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.083% BASE | SOLUTION;INHALATION | Prescription | No | AN | 207857 | SUN PHARM |
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