Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 207987
Company: BPI LABS
Company: BPI LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ABLYSINOL | ALCOHOL | 99% (1ML) | SOLUTION;INTRA-ARTERIAL | Prescription | None | Yes | No |
ABLYSINOL | ALCOHOL | 99% (5ML) | SOLUTION;INTRA-ARTERIAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
06/21/2018 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207987lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207987Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/207987Orig1s000TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/21/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207987lbl.pdf |