Home Applications 083135 Application 083135
Type ANDA
Sponsor GD SEARLE LLC 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 43 .
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 A083135-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 A083135-002 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982
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 3 · 86 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 2026-09-14 22:38:34 2026-08 A083135-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A083135-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 A083135-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A083135-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A083135-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A083135-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083135-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083135-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A083135-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A083135-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A083135-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A083135-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A083135-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A083135-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A083135-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A083135-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A083135-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A083135-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A083135-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A083135-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A083135-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A083135-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A083135-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A083135-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A083135-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A083135-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A083135-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A083135-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A083135-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A083135-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A083135-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A083135-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A083135-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A083135-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A083135-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A083135-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A083135-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A083135-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A083135-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A083135-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION Approved before 1982 74a2ff9319b5…
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 16 · 311 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE Henry Schein, Inc. 23c8f711-e458-479a-9ab0-dcc851311e24 2026-09-10 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Viscous LIDOCAINE HYDROCHLORIDE REMEDYREPACK INC. 6f8d20d2-6a91-4a5b-bfe8-f1baada38442 2026-09-03 Boxed warning, Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE XYLOCAINE MPF LIDOCAINE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst 1986c302-82a0-95a9-e063-6294a90a3339 2026-09-02 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE PAI Holdings, LLC dba PAI Pharma 9920daef-b156-4a14-b641-f714191ffb5c 2026-09-02 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE Sandoz Inc. dc476ebd-fd57-41c3-a649-7185a784a39f 2026-08-28 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE REMEDYREPACK INC. f824b48c-7039-4ce1-b3df-b3597aba5beb 2026-08-28 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE HUSTLE BUTTER NUMBING LIDOCAINE HYDROCHLORIDE H.B.D. D.I.S.T. INC. d7dfb312-6c80-4a2d-b8b2-d9891cb0b74e 2026-08-24 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Hospira, Inc. ad1ef0a8-88db-4648-c098-d009eaeb4e5b 2026-08-20 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Major Pharmaceuticals 04e8dd94-93a8-427d-81ab-a95793d86c36 2026-08-18 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE CVS Pain Relief Roll-On Lidocaine with Lavender LIDOCAINE HYDROCHLORIDE CVS Pharmacy 4aa53176-2103-b47b-e063-6394a90ac735 2026-08-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine LIDOCAINE HYDROCHLORIDE Sentiss Pharmaceuticals LLC 9b2d4f69-0c84-4956-b5c0-b4410acf62e0 2026-08-12 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Tattoo Wipe LIDOCAINE HYDROCHLORIDE MD Tattoo Company 369c1d16-597c-e1dc-e063-6394a90a3104 2026-08-06 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Hospira, Inc. 3b2dd84e-cee8-4e58-d494-395a65a353a0 2026-08-05 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Hospira, Inc. 9c18eaf1-4a0b-4916-70b2-88a827494711 2026-08-05 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE YYBA CORP 582a0001-da1e-909a-e063-6394a90a2b11 2026-08-03 Warnings Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Medical Purchasing Solutions, LLC 46404c7b-2ea4-e47b-e063-6294a90a779f 2026-08-03 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Xylocaine MPF LIDOCAINE HYDROCHLORIDE Sportpharm LLC 50aa6133-0776-4714-9821-fe8581f635ca 2026-07-28 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Aspercreme Lidocaine with Rosemary and Mint LIDOCAINE HYDROCHLORIDE Chattem, Inc. 9d40bfea-85d0-4943-83e9-0c16e79a011c 2026-07-28 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE AEROBURN LIDOCAINE HYDROCHLORIDE Aero Healthcare US LLC f8fa72db-5f7a-4158-a2b3-f8bc0e12df9f 2026-07-24 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE AEROBURN LIDOCAINE HYDROCHLORIDE Aero Healthcare US LLC a32cbc19-ec30-4634-b70d-664f2a2edd95 2026-07-24 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE