Application 203955

Type
ANDA
Sponsor
AKORN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION150MG/30ML (5MG/ML)NoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203955-001ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203955-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-113f01610625f2…
2019-09-15 20:21 UTC2019-09A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203955-001ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2016-04-11cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203955-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203955-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203955-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203955-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203955-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203955-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203955-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203955-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203955-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203955-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203955-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203955-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203955-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203955-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203955-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203955-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203955-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203955-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203955-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203955-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203955-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A203955-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203955-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203955-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203955-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A203955-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203955-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203955-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203955-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203955-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203955-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203955-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203955-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203955-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203955-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203955-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203955-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203955-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203955-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203955-001AP1cb3db0bc1861…

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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NAROPINROPIVACAINE HYDROCHLORIDEHenry Schein, Inc.6a2f1f6d-026f-4f39-aee0-5b75b8eb5c022026-07-22Warnings, Adverse reactionsName fallback
generic name: ROPIVACAINE HYDROCHLORIDE
NaropinROPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCcb6583ff-cde4-4280-aa5b-0bea2b8447922026-07-17Warnings, Adverse reactionsName fallback
generic name: ROPIVACAINE HYDROCHLORIDE
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEArmas Pharmaceuticals Inc.3849f5ce-d077-4318-935d-294be69481422026-05-20Warnings, Adverse reactionsName fallback
brand name: Ropivacaine Hydrochloride
generic name: ROPIVACAINE HYDROCHLORIDE
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDESportpharm LLC56b664ad-03e0-4bf3-8efa-40ce3e8d34982026-04-24Warnings, Adverse reactionsName fallback
brand name: Ropivacaine Hydrochloride
generic name: ROPIVACAINE HYDROCHLORIDE
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDESportpharm LLC7327766c-19f0-4d83-89c6-eb685e0d286c2026-04-24Warnings, Adverse reactionsName fallback
brand name: Ropivacaine Hydrochloride
generic name: ROPIVACAINE HYDROCHLORIDE
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEEugia US LLC3763b7b6-da49-4658-b93d-28f5da24d09e2026-04-21Warnings, Adverse reactionsName fallback
brand name: Ropivacaine Hydrochloride
generic name: ROPIVACAINE HYDROCHLORIDE
ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDEMylan Institutional LLC9e1d1b15-c224-4ff4-a39d-3b9cebfc84032026-03-13Warnings, Adverse reactionsName fallback
brand name: ROPIVACAINE HYDROCHLORIDE
generic name: ROPIVACAINE HYDROCHLORIDE
ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USA043b28cc-ce5c-4351-a646-704c381decb92026-03-09Warnings, Adverse reactionsName fallback
brand name: ROPIVACAINE HYDROCHLORIDE
generic name: ROPIVACAINE HYDROCHLORIDE
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.35743510-728d-407b-b501-cf019665cd352026-03-04Warnings, Adverse reactionsName fallback
brand name: Ropivacaine Hydrochloride
generic name: ROPIVACAINE HYDROCHLORIDE
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.3d465e02-fd09-41b8-847f-bfe99cb4a7122026-01-21Warnings, Adverse reactionsName fallback
brand name: Ropivacaine Hydrochloride
generic name: ROPIVACAINE HYDROCHLORIDE
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEProPharma Distribution3f793f80-57da-1599-e063-6394a90a1dab2025-12-18Warnings, Adverse reactionsName fallback
brand name: Ropivacaine Hydrochloride
generic name: ROPIVACAINE HYDROCHLORIDE
ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLA Pharmaceuticals, LLC5b3c642b-ab31-45fd-ac0b-b9f6e6cfe3a92025-12-08Warnings, Adverse reactionsName fallback
brand name: ROPIVACAINE HYDROCHLORIDE
generic name: ROPIVACAINE HYDROCHLORIDE
ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDEAnthea Pharma Private Limitedf2b54355-a596-4f97-aeaa-d93e3984c42d2025-11-01Warnings, Adverse reactionsName fallback
brand name: ROPIVACAINE HYDROCHLORIDE
generic name: ROPIVACAINE HYDROCHLORIDE
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDESomerset Therapeutics, LLCffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe642025-10-25Warnings, Adverse reactionsName fallback
brand name: Ropivacaine Hydrochloride
generic name: ROPIVACAINE HYDROCHLORIDE
ropivacaine hydrochlorideROPIVACAINE HYDROCHLORIDESagent Pharmaceuticals9572b3de-684c-4028-a577-5aa69ba6b02d2025-08-06Warnings, Adverse reactionsName fallback
brand name: ropivacaine hydrochloride
generic name: ROPIVACAINE HYDROCHLORIDE
ropivacaine hydrochlorideROPIVACAINE HYDROCHLORIDESagent Pharmaceuticals8c5c762f-d266-4b1a-809e-f11bfc89bc2d2025-08-06Warnings, Adverse reactionsName fallback
brand name: ropivacaine hydrochloride
generic name: ROPIVACAINE HYDROCHLORIDE
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEFRESENIUS KABI USA, LLCda4a7675-97bf-4d2a-9fdc-c1b4b29991262025-06-30Warnings, Adverse reactionsName fallback
brand name: Ropivacaine Hydrochloride
generic name: ROPIVACAINE HYDROCHLORIDE
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDECaplin Steriles Limiteda9010ea8-0923-44e4-a7c7-7d65d37d06db2025-06-24Warnings, Adverse reactionsName fallback
brand name: Ropivacaine Hydrochloride
generic name: ROPIVACAINE HYDROCHLORIDE
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDECivica, Inc.1fb8e90a-4141-4707-8be6-31f2da5c8fd52024-11-07Warnings, Adverse reactionsName fallback
brand name: Ropivacaine Hydrochloride
generic name: ROPIVACAINE HYDROCHLORIDE
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.d00bfdee-d3e9-4faf-b079-43ac1add51b32024-09-05Warnings, Adverse reactionsName fallback
brand name: Ropivacaine Hydrochloride
generic name: ROPIVACAINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-081Ropivacaine HydrochlorideRopivacaine HydrochlorideAkornANDACurrent
17478-081Ropivacaine HydrochlorideRopivacaine HydrochlorideAkornANDACurrent
17478-081Ropivacaine HydrochlorideRopivacaine HydrochlorideAkorn, Inc.ANDACurrent
17478-081Ropivacaine HydrochlorideRopivacaine HydrochlorideAkorn, Inc.ANDACurrent
17478-081Ropivacaine HydrochlorideRopivacaine HydrochlorideAkorn, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32482ORIG2016-04-13