Home Applications 040911 Application 040911
Type ANDA
Sponsor SEPTODONT INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LIDOCAINE LIDOCAINE OINTMENT;TOPICAL 5% 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 A040911-001 LIDOCAINE LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040911-001 AT
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040911-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2011-05-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 · 21 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0362-0221 Lidocaine Lidocaine Septodont, Inc. ANDA Current 0362-0221 Lidocaine Lidocaine Septodont, Inc. ANDA Current 0362-0221 Lidocaine Lidocaine Septodont, Inc. ANDA Current 0362-0221 Lidocaine Lidocaine Septodont, Inc. ANDA Current 45865-837 Lidocaine Lidocaine medsource pharmaceuticals ANDA Current 45865-911 Lidocaine Lidocaine medsource pharmaceuticals ANDA Current 50383-933 Lidocaine Lidocaine Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-933 Lidocaine Lidocaine Hi-Tech Pharmacal Co., Inc. ANDA Current 50436-0933 Lidocaine Lidocaine Unit Dose Services ANDA Current 51407-325 Lidocaine Lidocaine Golden State Medical Supply ANDA Current 51407-325 Lidocaine Lidocaine Golden State Medical Supply, Inc. ANDA Current 55700-384 Lidocaine Lidocaine Lake Erie Medical DBA Quality Care Products LLC ANDA Current 57539-0221 Lidocaine Lidocaine Novocol Inc. ANDA Current 60429-824 Lidocaine Lidocaine GSMS, Incorporated ANDA Current 60429-824 Lidocaine Lidocaine Golden State Medical Supply, Inc. ANDA Current 60429-824 Lidocaine Lidocaine Golden State Medical Supply, Inc. ANDA Current 68788-7007 Lidocaine Lidocaine Preferred Pharmaceuticals Inc. ANDA Current 70518-0854 Lidocaine Lidocaine REMEDYREPACK INC. ANDA Current 70518-0855 Lidocaine Lidocaine REMEDYREPACK INC. ANDA Current 70518-0855 Lidocaine Lidocaine REMEDYREPACK INC. ANDA Current 76420-036 Lidocaine Lidocaine Asclemed USA, Inc. ANDA Current