Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204395
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM PHENYLBUTYRATE | SODIUM PHENYLBUTYRATE | 500MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
04/15/2016 | ORIG-1 | Approval |
Label is not available on this site. |
SODIUM PHENYLBUTYRATE
TABLET;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BUPHENYL | SODIUM PHENYLBUTYRATE | 500MG | TABLET;ORAL | Prescription | Yes | AB | 020572 | HORIZON THERAP US |
SODIUM PHENYLBUTYRATE | SODIUM PHENYLBUTYRATE | 500MG | TABLET;ORAL | Prescription | No | AB | 204395 | ENDO OPERATIONS |
SODIUM PHENYLBUTYRATE | SODIUM PHENYLBUTYRATE | 500MG | TABLET;ORAL | Prescription | No | AB | 216462 | GLENMARK PHARMS LTD |