Application 211150

Related Records#

• Company: HARMONY

Application Products#

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 10 matching rows.

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.

Product history page 1 of 3 · 84 observed states.

Observed Orange Book normalized TE history#

Observed Orange Book patent history#

Patent history page 1 of 11 · 420 observed states.

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 318 observed states.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

Documents#