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
ALOPRIM از شرکت MYLAN INSTITUTIONAL
New Drug Application (NDA): 020298
Company: MYLAN INSTITUTIONAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALOPRIM | ALLOPURINOL SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription |
AP |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 05/17/1996 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
PRIORITY; Orphan |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/16/2020 | SUPPL-13 | Labeling-Container/Carton Labels, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020298Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020298Orig1s013ltr.pdf |
||
| 08/28/2020 | SUPPL-10 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020298s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020298Orig1s010ltr.pdf |
||
| 05/13/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/09/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/12/2000 | SUPPL-1 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/020298Orig1s001.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/16/2020 | SUPPL-13 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020298Orig1s013lbl.pdf | |
| 12/16/2020 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020298Orig1s013lbl.pdf | |
| 08/28/2020 | SUPPL-10 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020298s010lbl.pdf | |
| 05/12/2000 | SUPPL-1 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/020298Orig1s001.pdf |
ALOPRIM
INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALLOPURINOL SODIUM | ALLOPURINOL SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 076870 | WEST-WARD PHARMS INT |
| ALOPRIM | ALLOPURINOL SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 020298 | MYLAN INSTITUTIONAL |
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