Application 212808

Type
ANDA
Sponsor
CAPLIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION40MG/20ML (2MG/ML)NoNo
002ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION100MG/20ML (5MG/ML)NoNo
003ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION150MG/30ML (5MG/ML)NoNo
004ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION200MG/20ML (10MG/ML)NoNo
005ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION200MG/100ML (2MG/ML)NoNo
006ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLUTION;INJECTION400MG/200ML (2MG/ML)NoNo

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212808-001ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2020-04-09
A212808-002ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-09
A212808-003ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-09
A212808-004ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2020-04-09
A212808-005ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-23
A212808-006ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A212808-001AP
A212808-002AP
A212808-003AP
A212808-004AP
A212808-005AP
A212808-006AP

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 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212808-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2020-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212808-002ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212808-003ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212808-004ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2020-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212808-005ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212808-006ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2020-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-002ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-003ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-004ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2020-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-005ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-006ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A212808-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2020-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212808-002ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212808-003ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212808-004ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2020-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212808-005ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212808-006ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2020-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-002ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-003ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-004ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2020-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-005ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-006ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2020-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-002ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-003ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-004ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2020-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-005ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-006ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2020-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-002ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-003ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-004ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2020-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-005ROPIVACAINE HYDROCHLORIDE200MG/100ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-006ROPIVACAINE HYDROCHLORIDE400MG/200ML (2MG/ML)SOLUTION / INJECTIONAP2024-05-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212808-001ROPIVACAINE HYDROCHLORIDE40MG/20ML (2MG/ML)SOLUTION / INJECTIONAP2020-04-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212808-002ROPIVACAINE HYDROCHLORIDE100MG/20ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212808-003ROPIVACAINE HYDROCHLORIDE150MG/30ML (5MG/ML)SOLUTION / INJECTIONAP2020-04-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212808-004ROPIVACAINE HYDROCHLORIDE200MG/20ML (10MG/ML)SOLUTION / INJECTIONAP2020-04-092680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212808-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212808-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212808-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212808-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212808-005AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212808-006AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-005AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212808-006AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212808-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212808-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212808-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212808-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212808-005AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212808-006AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-005AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212808-006AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-005AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212808-006AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-004AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-005AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212808-006AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212808-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212808-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212808-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212808-004AP12680178bc6a6…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEArmas Pharmaceuticals Inc.3849f5ce-d077-4318-935d-294be69481422026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212808
application number: ANDA212808
ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDESOLA Pharmaceuticals, LLC5b3c642b-ab31-45fd-ac0b-b9f6e6cfe3a92025-12-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212808
application number: ANDA212808
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEFRESENIUS KABI USA, LLCda4a7675-97bf-4d2a-9fdc-c1b4b29991262025-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212808
application number: ANDA212808
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDECaplin Steriles Limiteda9010ea8-0923-44e4-a7c7-7d65d37d06db2025-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212808
application number: ANDA212808
ndc (product): 65145-110
ndc (product): 65145-109
ndc (product): 65145-107
ndc (product): 65145-108
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDECivica, Inc.1fb8e90a-4141-4707-8be6-31f2da5c8fd52024-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212808
application number: ANDA212808
ndc (product): 72572-707
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDENorthStar Rx LLC61896fe6-4a5a-4e0f-bfc2-44265bc1f2c12024-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212808
application number: ANDA212808
ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDEBaxter Healthcare Corporation781d4b7f-7556-4695-8d48-7772d7a0d8e92023-06-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212808
application number: ANDA212808
ndc (product): 43066-023
ndc (product): 43066-015
ndc (product): 43066-019
ndc (product): 43066-027

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43066-015ROPIVACAINE HYDROCHLORIDEropivacaine hydrochlorideBaxter Healthcare CorporationANDACurrent
43066-015ROPIVACAINE HYDROCHLORIDEropivacaine hydrochlorideBaxter Healthcare CorporationANDACurrent
43066-015ROPIVACAINE HYDROCHLORIDEropivacaine hydrochlorideBaxter Healthcare CorporationANDACurrent
43066-015ROPIVACAINE HYDROCHLORIDEropivacaine hydrochlorideBaxter Healthcare CorporationANDACurrent
43066-019ROPIVACAINE HYDROCHLORIDEropivacaine hydrochlorideBaxter Healthcare CorporationANDACurrent
43066-019ROPIVACAINE HYDROCHLORIDEropivacaine hydrochlorideBaxter Healthcare CorporationANDACurrent
43066-019ROPIVACAINE HYDROCHLORIDEropivacaine hydrochlorideBaxter Healthcare CorporationANDACurrent
43066-019ROPIVACAINE HYDROCHLORIDEropivacaine hydrochlorideBaxter Healthcare CorporationANDACurrent
43066-023ROPIVACAINE HYDROCHLORIDEropivacaine hydrochlorideBaxter Healthcare CorporationANDACurrent
43066-023ROPIVACAINE HYDROCHLORIDEropivacaine hydrochlorideBaxter Healthcare CorporationANDACurrent
43066-023ROPIVACAINE HYDROCHLORIDEropivacaine hydrochlorideBaxter Healthcare CorporationANDACurrent
43066-023ROPIVACAINE HYDROCHLORIDEropivacaine hydrochlorideBaxter Healthcare CorporationANDACurrent
43066-027ROPIVACAINE HYDROCHLORIDEropivacaine hydrochlorideBaxter Healthcare CorporationANDACurrent
43066-027ROPIVACAINE HYDROCHLORIDEropivacaine hydrochlorideBaxter Healthcare CorporationANDACurrent
43066-027ROPIVACAINE HYDROCHLORIDEropivacaine hydrochlorideBaxter Healthcare CorporationANDACurrent
43066-027ROPIVACAINE HYDROCHLORIDEropivacaine hydrochlorideBaxter Healthcare CorporationANDACurrent
65145-107Ropivacaine HydrochlorideRopivacaine HydrochlorideCaplin Steriles LimitedANDACurrent
65145-108Ropivacaine HydrochlorideRopivacaine HydrochlorideCaplin Steriles LimitedANDACurrent
65145-109Ropivacaine HydrochlorideRopivacaine HydrochlorideCaplin Steriles LimitedANDACurrent
65145-110Ropivacaine HydrochlorideRopivacaine HydrochlorideCaplin Steriles LimitedANDACurrent
72572-707Ropivacaine HydrochlorideRopivacaine HydrochlorideCivica, Inc.ANDACurrent