Home Applications 214339 Application 214339
Type ANDA
Sponsor ASPIRO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% No No 002 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214339-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 A214339-002 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 · 68 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 A214339-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214339-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214339-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214339-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214339-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214339-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214339-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214339-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214339-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214339-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214339-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214339-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214339-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214339-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214339-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214339-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214339-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214339-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214339-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214339-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214339-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214339-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214339-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214339-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214339-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214339-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214339-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214339-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214339-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A214339-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214339-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214339-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214339-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A214339-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214339-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A214339-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214339-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A214339-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214339-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2021-11-08 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A214339-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2021-11-08 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 31722-117 Lidocaine Hydrochloride Lidocaine Hydrochloride Camber Pharmaceuticals, Inc. ANDA Current 31722-117 Lidocaine Hydrochloride Lidocaine Hydrochloride Camber Pharmaceuticals, Inc. ANDA Current 31722-117 Lidocaine Hydrochloride Lidocaine Hydrochloride Camber Pharmaceuticals, Inc. ANDA Current 31722-117 Lidocaine Hydrochloride Lidocaine Hydrochloride Camber Pharmaceuticals, Inc. ANDA Current 31722-118 Lidocaine Hydrochloride Lidocaine Hydrochloride Camber Pharmaceuticals, Inc. ANDA Current 31722-118 Lidocaine Hydrochloride Lidocaine Hydrochloride Camber Pharmaceuticals, Inc. ANDA Current 31722-118 Lidocaine Hydrochloride Lidocaine Hydrochloride Camber Pharmaceuticals, Inc. ANDA Current 31722-118 Lidocaine Hydrochloride Lidocaine Hydrochloride Camber Pharmaceuticals, Inc. ANDA Current