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
BENZEDRINE از شرکت SMITH KLINE & FRENCH
Abbreviated New Drug Application (ANDA): 083900
Company: SMITH KLINE & FRENCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENZEDRINE | AMPHETAMINE SULFATE | 5MG | Tablet; Oral | Discontinued |
None |
No | No |
| BENZEDRINE | AMPHETAMINE SULFATE | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/26/1976 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/083900_amphetamine-sulfate_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/11/1981 | SUPPL-9 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S9.pdf |
||
| 12/14/1979 | SUPPL-8 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S8.pdf |
||
| 05/11/1982 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S7.pdf |
|
| 02/06/1979 | SUPPL-6 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S6.pdf |
||
| 02/11/1981 | SUPPL-5 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S5.pdf |
||
| 11/21/1978 | SUPPL-4 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S4.pdf |
||
| 11/21/1978 | SUPPL-3 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S3.pdf |
||
| 05/11/1977 | SUPPL-2 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S2.pdf |
||
| 04/15/1976 | SUPPL-1 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S1.pdf |
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