Home Applications 070554 Application 070554
Type ANDA
Sponsor FRESENIUS KABI USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SENSORCAINE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.75% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A070554-001 SENSORCAINE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / INJECTION AP 1986-05-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070554-001 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 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SENSORCAINE BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE Fresenius Kabi USA, LLC bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb 2023-04-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070554 application number: ANDA070554 ndc (product): 63323-472
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 63323-472 SENSORCAINE BUPIVACAINE HYDROCHLORIDE Fresenius Kabi USA, LLC ANDA Current 63323-472 SENSORCAINE BUPIVACAINE HYDROCHLORIDE Fresenius Kabi USA, LLC ANDA Current