FDA.reportPublic FDA data

Application 219935

Type
NDA
Sponsor
SAGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FAMOTIDINEFAMOTIDINESOLUTION;INTRAVENOUS20MG/5ML (4MG/ML)YesYes
002FAMOTIDINEFAMOTIDINESOLUTION;INTRAVENOUS40MG/10ML (4MG/ML)YesYes
003FAMOTIDINEFAMOTIDINESOLUTION;INTRAVENOUS200MG/50ML (4MG/ML)YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219935-001FAMOTIDINEFAMOTIDINE20MG/5ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-16
N219935-002FAMOTIDINEFAMOTIDINE40MG/10ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-16
N219935-003FAMOTIDINEFAMOTIDINE200MG/50ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-16

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
2026-02-19 14:30 UTC2026-02N219935-001FAMOTIDINE20MG/5ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219935-002FAMOTIDINE40MG/10ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219935-003FAMOTIDINE200MG/50ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219935-001FAMOTIDINE20MG/5ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219935-002FAMOTIDINE40MG/10ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219935-003FAMOTIDINE200MG/50ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N219935-001FAMOTIDINE20MG/5ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219935-002FAMOTIDINE40MG/10ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219935-003FAMOTIDINE200MG/50ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-166a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219935-001FAMOTIDINE20MG/5ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219935-002FAMOTIDINE40MG/10ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219935-003FAMOTIDINE200MG/50ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-16a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINESagent Pharmaceuticals9710995d-b518-40ce-bc2b-8b5dcf002c312026-06-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 219935
application number: NDA219935

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82900ORIG 2025-07-21
82888ORIG 2025-07-17