FDA.reportPublic FDA data

JUVMO

Product NDC
0074-6210
Requested package NDC
0074-6210-30
11-digit product format
000746210
Labeler code
0074
Product ID
0074-6210_b8de6e40-0be5-495c-8f8b-f171dbf39650
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tavapadon
Dosage form
TABLET
Route
ORAL
Labeler
AbbVie Inc.
Application
NDA220415
Marketing category
NDA
Marketing start
2026-09-25
Substance
TAVAPADON
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220415-001JUVMO (COPACKAGED)TAVAPADON0.25MG;1MGTABLET / ORALRLD2026-09-25
N220415-002JUVMOTAVAPADON5MGTABLET / ORALRLD2026-09-25
N220415-003JUVMOTAVAPADON10MGTABLET / ORALRLD2026-09-25
N220415-004JUVMOTAVAPADON15MGTABLET / ORALRLD, RS2026-09-25

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N220415-001JUVMO (COPACKAGED)0.25MG;1MGTABLET / ORALRLD2026-09-25c2088c7a36db…
2026-10-15 13:18:302026-09N220415-002JUVMO5MGTABLET / ORALRLD2026-09-25c2088c7a36db…
2026-10-15 13:18:302026-09N220415-003JUVMO10MGTABLET / ORALRLD2026-09-25c2088c7a36db…
2026-10-15 13:18:302026-09N220415-004JUVMO15MGTABLET / ORALRLD, RS2026-09-25c2088c7a36db…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
JUVMO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAVAPADON10 mg/1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0074-6210-300007462103030 TABLET in 1 BOTTLE (0074-6210-30) 30 tablet2026-09-25NoNoCurrent