Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020573
Company: HORIZON THERAP US
Company: HORIZON THERAP US
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 |
Review (PDF)
|
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 |
---|---|---|---|---|---|
07/29/2022 | SUPPL-22 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020572s025,020573s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020572Orig1s025,020573Orig1s022ltr.pdf | |
08/05/2013 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/31/2009 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
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 |
---|---|---|---|---|---|
07/29/2022 | SUPPL-22 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020572s025,020573s022lbl.pdf | |
07/29/2022 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020572s025,020573s022lbl.pdf | |
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 US |
SODIUM PHENYLBUTYRATE | SODIUM PHENYLBUTYRATE | 3GM/TEASPOONFUL | POWDER;ORAL | Prescription | No | AB | 203918 | ENDO OPERATIONS |
SODIUM PHENYLBUTYRATE | SODIUM PHENYLBUTYRATE | 3GM/TEASPOONFUL | POWDER;ORAL | Prescription | No | AB | 202819 | SIGMAPHARM LABS LLC |