FDA.reportPublic FDA data

Application 040014

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDESOLUTION;ORAL2%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040014-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2%SOLUTION / ORAL1995-07-10

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALATRS1995-07-10cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040014-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORAL1995-07-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040014-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040014-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040014-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040014-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040014-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040014-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040014-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A040014-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040014-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040014-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040014-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A040014-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040014-001AT1ea99ee380514…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040014-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040014-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040014-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040014-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040014-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040014-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040014-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040014-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040014-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040014-001AT1cb3db0bc1861…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.5a41d694-4628-4911-e053-2991aa0a91e52024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040014
application number: ANDA040014
ndc (product): 66267-962

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0775Lidocaine HydrochlorideLidocaine HydrochlorideAtlantic Biologicals CorpsANDACurrent
17856-0775Lidocaine HydrochlorideLidocaine HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0775Lidocaine HydrochlorideLidocaine HydrochlorideAtlantic Biologicals CorpsANDACurrent
21695-783Lidocaine HydrochlorideLidocaine HydrochlorideRebel Distributors CorpANDACurrent
24451-775Lidocaine HydrochlorideLidocaine HydrochlorideLLC Federal SolutionsANDACurrent
49999-140Lidocaine HydrochlorideLidocaine HydrochlorideLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
50090-0255Lidocaine HydrochlorideLidocaine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0255Lidocaine HydrochlorideLidocaine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0255Lidocaine HydrochlorideLidocaine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0255Lidocaine HydrochlorideLidocaine HydrochlorideA-S Medication SolutionsANDACurrent
50383-775Lidocaine HydrochlorideLidocaine HydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-775Lidocaine HydrochlorideLidocaine HydrochlorideAkornANDACurrent
50383-775Lidocaine HydrochlorideLidocaine HydrochlorideAkornANDACurrent
50383-775Lidocaine HydrochlorideLidocaine HydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-775Lidocaine HydrochlorideLidocaine HydrochlorideAkornANDACurrent
50383-775Lidocaine HydrochlorideLidocaine HydrochlorideAkornANDACurrent
50436-0775Lidocaine HydrochlorideLidocaine HydrochlorideUnit Dose ServicesANDACurrent
51021-440Professional Medicated DNA CollectionLidocaine Hydrochloride and GlycerinSircle Laboratories, LLCANDACurrent
53002-3430Lidocaine HydrochlorideLidocaine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
55154-9626Lidocaine HydrochlorideLidocaine HydrochlorideCardinal Health 107, LLCANDACurrent
55154-9626Lidocaine HydrochlorideLidocaine HydrochlorideCardinal HealthANDACurrent
55154-9626Lidocaine HydrochlorideLidocaine HydrochlorideCardinal HealthANDACurrent
61919-520LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-520LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEDIRECT RXANDACurrent
66267-962Lidocaine HydrochlorideLidocaine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
66267-962Lidocaine HydrochlorideLidocaine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9799Lidocaine HydrochlorideLidocaine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9799Lidocaine HydrochlorideLidocaine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9799Lidocaine HydrochlorideLidocaine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9799Lidocaine HydrochlorideLidocaine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9799Lidocaine HydrochlorideLidocaine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
69938-151Medicated DNA Collection Kitlidocaine hydrochloride, glycerinTrueFit RX LLCANDACurrent
70518-1894Lidocaine HydrochlorideLidocaine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1894Lidocaine HydrochlorideLidocaine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1894Lidocaine HydrochlorideLidocaine HydrochlorideREMEDYREPACK INC.ANDACurrent
70529-441DX1 OraGenomic Medicated DNA Collection ScreenLidocaine HydrochlorideIT3 Medical LLCANDACurrent
70529-441DX1 OraGenomic Medicated DNA Collection ScreenLidocaine HydrochlorideIT3 Medical LLCANDACurrent
70529-441DX1 OraGenomic Medicated DNA Collection ScreenLidocaine HydrochlorideIT3 Medical LLCANDACurrent
70529-442DX2 OraGenomic Medicated DNA Collection ScreenLidocaine HydrochlorideIT3 Medical LLCANDACurrent
70529-442DX2 OraGenomic Medicated DNA Collection ScreenLidocaine HydrochlorideIT3 Medical LLCANDACurrent
70529-442DX2 OraGenomic Medicated DNA Collection ScreenLidocaine HydrochlorideIT3 Medical LLCANDACurrent
70859-043Medicated Buccal DNA Collection KitLidocaine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70859-043Medicated Buccal DNA Collection KitLidocaine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70859-044Medicated Buccal DNA Collection Kit 2Lidocaine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70859-044Medicated Buccal DNA Collection Kit 2Lidocaine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent