Home Applications 209321 Application 209321
Type NDA
Sponsor JACOBUS PHARM CO INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RUZURGI AMIFAMPRIDINE TABLET;ORAL 10MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog .
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N209321-001 RUZURGI 10MG TABLET / ORAL RLD, RS 2019-05-06 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N209321-001 RUZURGI 10MG TABLET / ORAL RLD, RS 2019-05-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209321-001 RUZURGI 10MG TABLET / ORAL RLD, RS 2019-05-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209321-001 RUZURGI 10MG TABLET / ORAL RLD, RS 2019-05-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209321-001 RUZURGI 10MG TABLET / ORAL RLD, RS 2019-05-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209321-001 RUZURGI 10MG TABLET / ORAL RLD, RS 2019-05-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209321-001 RUZURGI 10MG TABLET / ORAL RLD, RS 2019-05-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209321-001 RUZURGI 10MG TABLET / ORAL RLD, RS 2019-05-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209321-001 RUZURGI 10MG TABLET / ORAL RLD, RS 2019-05-06 ea99ee380514…
Observed Orange Book exclusivity history# NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 49938-110 Ruzurgi Amifampridine Jacobus Pharmaceutical Company,Inc NDA Current 49938-110 Ruzurgi Amifampridine Jacobus Pharmaceutical Company,Inc NDA Current 49938-110 RUZURGI amifampridine Jacobus Pharmaceutical Company, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 70076 ORIG 2022-02-04 64398 SUPPL 2020-08-24 59050 ORIG 2019-06-13 58601 ORIG 2019-05-07 58600 ORIG 2019-05-07 58597 ORIG 2019-05-07 58596 ORIG 2019-05-07