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
AMINOPHYLLIN از شرکت GD SEARLE LLC
New Drug Application (NDA): 002386
Company: GD SEARLE LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMINOPHYLLIN | AMINOPHYLLINE | 100MG | TABLET;ORAL | Discontinued |
None |
No | No |
AMINOPHYLLIN | AMINOPHYLLINE | 200MG | TABLET;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 |
---|---|---|---|---|---|---|---|
04/19/1940 | 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 |
---|---|---|---|---|---|
08/27/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
08/14/1989 | SUPPL-14 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
08/27/1991 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
08/27/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
12/09/1983 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/14/1981 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
04/14/1981 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/23/1980 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
06/13/1980 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/13/1980 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/15/1980 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
01/18/1980 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/01/1977 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/01/1977 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
08/01/1977 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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