FDA Approval for SUSTOL issued to HERON THERAPS INC
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 022445
Company: HERON THERAPS INC
Company: HERON THERAPS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SUSTOL | GRANISETRON | 10MG/0.4ML (10MG/0.4ML) | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | 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 |
|---|---|---|---|---|---|---|---|
| 08/09/2016 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022445s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022445Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/022445Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/26/2023 | SUPPL-10 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022445Orig1s010ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/09/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022445s000lbl.pdf |