Home Applications 210762 Application 210762
Type ANDA
Sponsor FRESENIUS KABI USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FENTANYL CITRATE PRESERVATIVE FREE FENTANYL CITRATE INJECTABLE;INJECTION EQ 0.05MG BASE/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210762-001 FENTANYL CITRATE PRESERVATIVE FREE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210762-001 AP
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 2 of 2 · 44 observed 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 2022-10-28 04:53 UTC 2022-10 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 63323-806 Fentanyl Citrate Fentanyl Citrate Fresenius Kabi USA, LLC ANDA Current 63323-806 Fentanyl Citrate Fentanyl Citrate Fresenius Kabi USA, LLC ANDA Current 63323-806 Fentanyl Citrate Fentanyl Citrate Fresenius Kabi USA, LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 59090 ORIG 2019-06-17