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
AMINOPHYLLINE از شرکت ROXANE
Abbreviated New Drug Application (ANDA): 088126
Company: ROXANE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMINOPHYLLINE | AMINOPHYLLINE | 105MG/5ML | SOLUTION;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/19/1983 | 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 |
|---|---|---|---|---|---|
| 02/17/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1998 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/16/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1999 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/01/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/1992 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/03/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/22/1990 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/06/1990 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/24/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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