Home Applications 212086 Application 212086
Type ANDA
Sponsor FRESENIUS KABI USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FENTANYL CITRATE FENTANYL CITRATE INJECTABLE;INJECTION EQ 0.05MG BASE/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A212086-001 FENTANYL CITRATE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212086-001 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.
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 2026-02-19 14:30 UTC 2026-02 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION 2020-09-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 a50c72e98297…
Observed Orange Book normalized TE history# 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 63323-808 Fentanyl Citrate Fentanyl Citrate Fresenius Kabi USA, LLC ANDA Current 63323-817 Fentanyl Citrate Fentanyl Citrate Fresenius Kabi USA, LLC ANDA Current