Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209321
Company: JACOBUS PHARM CO INC
Company: JACOBUS PHARM CO INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RUZURGI | AMIFAMPRIDINE | 10MG | TABLET;ORAL | None (Tentative Approval) | 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 |
|---|---|---|---|---|---|---|---|
| 05/06/2019 | ORIG-2 | Tentative Approval | Efficacy | PRIORITY; Orphan |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209321Orig2s000_TAltr.pdf |
| 02/01/2022 | ORIG-1 | Tentative Approval | Type 2 - New Active Ingredient | PRIORITY; Orphan |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209321Orig1s000TA_ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/01/2022 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |