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
BUPHENYL از شرکت HORIZON THERAP
New Drug Application (NDA): 020573
Company: HORIZON THERAP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPHENYL | SODIUM PHENYLBUTYRATE | 3GM/TEASPOONFUL | POWDER;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 04/30/1996 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY; Orphan |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020573Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/05/2013 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/2009 | SUPPL-15 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020572s016,020573s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020572s016,020573s015ltr.pdf |
||
| 10/09/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 11/07/1996 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/31/2009 | SUPPL-15 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020572s016,020573s015lbl.pdf |
BUPHENYL
POWDER;ORAL; 3GM/TEASPOONFUL
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPHENYL | SODIUM PHENYLBUTYRATE | 3GM/TEASPOONFUL | POWDER;ORAL | Prescription | Yes | AB | 020573 | HORIZON THERAP |
| SODIUM PHENYLBUTYRATE | SODIUM PHENYLBUTYRATE | 3GM/TEASPOONFUL | POWDER;ORAL | Prescription | No | AB | 203918 | PAR PHARM |
| SODIUM PHENYLBUTYRATE | SODIUM PHENYLBUTYRATE | 3GM/TEASPOONFUL | POWDER;ORAL | Prescription | No | AB | 202819 | SIGMAPHARM LABS LLC |
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