Application 203082

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREELIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION1%NoNo
002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREELIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION2%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREELIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2013-03-14
A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREELIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2013-03-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203082-001AP
A203082-002AP

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14782e0a99824c…
2021-12-28 21:50 UTC2021-12A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203082-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203082-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203082-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203082-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203082-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203082-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203082-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203082-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203082-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203082-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203082-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203082-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203082-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203082-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203082-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203082-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203082-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203082-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203082-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203082-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203082-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203082-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203082-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203082-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203082-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203082-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203082-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203082-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203082-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203082-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203082-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203082-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203082-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203082-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203082-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203082-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203082-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203082-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203082-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203082-002AP1782e0a99824c…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESportpharm LLC5b74b6f4-f26f-4243-8060-cd17779079842026-05-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203082
application number: ANDA203082
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEEugia US LLC89701fac-7536-4f16-87fb-f4cc121e74ee2026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203082
application number: ANDA203082
ndc (product): 55150-164
ndc (product): 55150-162
ndc (product): 55150-165
ndc (product): 55150-161
ndc (product): 55150-163
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHenry Schein, Inc.23c8f711-e458-479a-9ab0-dcc851311e242025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203082
application number: ANDA203082
ndc (product): 0404-9897
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEEugia US LLC9916b09d-a116-469d-92d5-60e50ea9782b2025-02-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203082
application number: ANDA203082
ndc (product): 55150-164
ndc (product): 55150-162
ndc (product): 55150-165
ndc (product): 55150-161
ndc (product): 55150-163
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf4c19cf5-c8b1-5e9f-e053-2995a90aee532024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203082
application number: ANDA203082
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst1b584ef0-3663-0d2a-e063-6394a90a17572024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203082
application number: ANDA203082
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirstc901016e-9293-79dd-e053-2a95a90a0fda2024-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203082
application number: ANDA203082
ndc (product): 51662-1543
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC79798b21-026d-1b4c-e053-2a91aa0a01292023-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203082
application number: ANDA203082
ndc (product): 71872-7144
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.55a8372e-70d6-4b70-ac95-5226d0f5812a2023-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203082
application number: ANDA203082
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.b8803e38-fe30-48ec-9399-013f2880e0eb2020-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203082
application number: ANDA203082
ndc (product): 76420-080

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9897LIDOCAINE HYDROCHLORIDElidocaine hydrochlorideHenry Schein, Inc.ANDACurrent
0404-9897LIDOCAINE HYDROCHLORIDElidocaine hydrochlorideHenry Schein, Inc.ANDACurrent
51662-1543LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1543LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-095LIDOCAINE HYDROCHLORIDElidocaine hydrochlorideGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-095LIDOCAINE HYDROCHLORIDElidocaine hydrochlorideGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-095LIDOCAINE HYDROCHLORIDElidocaine hydrochlorideGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-095LIDOCAINE HYDROCHLORIDElidocaine hydrochlorideGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-095LIDOCAINE HYDROCHLORIDElidocaine hydrochlorideGeneral Injectables & Vaccines, Inc.ANDACurrent
53225-3600ReadySharp LidocaineLIDOCAINE HYDROCHLORIDETerrain PharmaceuticalsANDACurrent
53225-3600ReadySharp LidocaineLIDOCAINE HYDROCHLORIDETerrain PharmaceuticalsANDACurrent
53225-3600ReadySharp LidocaineLIDOCAINE HYDROCHLORIDETerrain PharmaceuticalsANDACurrent
53225-3600ReadySharp LidocaineLIDOCAINE HYDROCHLORIDETerrain PharmaceuticalsANDACurrent
55150-161Lidocaine HydrochlorideLidocaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-161Lidocaine HydrochlorideLidocaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-161Lidocaine HydrochlorideLidocaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-161Lidocaine HydrochlorideLidocaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-162Lidocaine HydrochlorideLidocaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-162Lidocaine HydrochlorideLidocaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-162Lidocaine HydrochlorideLidocaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-162Lidocaine HydrochlorideLidocaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-163Lidocaine HydrochlorideLidocaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-163Lidocaine HydrochlorideLidocaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-163Lidocaine HydrochlorideLidocaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-163Lidocaine HydrochlorideLidocaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-164Lidocaine HydrochlorideLidocaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-164Lidocaine HydrochlorideLidocaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-164Lidocaine HydrochlorideLidocaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-164Lidocaine HydrochlorideLidocaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-165Lidocaine HydrochlorideLidocaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-165Lidocaine HydrochlorideLidocaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-165Lidocaine HydrochlorideLidocaine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-165Lidocaine HydrochlorideLidocaine HydrochlorideAuroMedics Pharma LLCANDACurrent
71872-7144Lidocaine HydrochlorideLidocaine HydrochlorideMedical Purchasing Solutions, LLCANDACurrent
71872-7144Lidocaine HydrochlorideLidocaine HydrochlorideMedical Purchasing Solutions, LLCANDACurrent
76420-080Lidocaine HydrochlorideLidocaine HydrochlorideAsclemed USA, Inc.ANDACurrent