Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205394
Company: GENSCO
Company: GENSCO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RIZAFILM | RIZATRIPTAN BENZOATE | EQ 10MG BASE | FILM;ORAL | 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 |
---|---|---|---|---|---|---|---|
04/14/2023 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205394s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205394Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/205394Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/11/2023 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205394s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205394Orig1s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/11/2023 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205394s002lbl.pdf | |
12/11/2023 | SUPPL-2 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205394s002lbl.pdf | |
04/14/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205394s000lbl.pdf |