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 IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER از شرکت HOSPIRA
New Drug Application (NDA): 018924
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | AMINOPHYLLINE | 100MG/100ML | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | AMINOPHYLLINE | 200MG/100ML | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | AMINOPHYLLINE | 400MG/100ML | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | AMINOPHYLLINE | 500MG/100ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 12/12/1984 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/10/1998 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/10/1997 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/1997 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/1996 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/13/1996 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/09/1996 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/09/1996 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/13/1992 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/02/1991 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/05/1992 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/22/1990 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/05/1992 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/26/1986 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1986 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1986 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/10/1985 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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