FDA.reportPublic FDA data

Application 078601

Type
ANDA
Sponsor
NAVINTA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDEINJECTABLE; INJECTION5MG/ML(0.5%)NoNo
002ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION150MG/30ML (5MG/ML)NoNo
003ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION200MG/20ML (10MG/ML)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
A078601-002ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2014-07-17
A078601-003ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2014-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078601-002AP
A078601-003AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078601-002ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2014-07-17a50c72e98297…
2026-08-01 22:54:322026-06A078601-003ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2014-07-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078601-002AP1a50c72e98297…
2026-08-01 22:54:322026-06A078601-003AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 29 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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3140Ropivacaine HydrochlorideRopivacaine HydrochlorideSandoz IncANDACurrent
0781-3142Ropivacaine HydrochlorideRopivacaine HydrochlorideSandoz IncANDACurrent