Application 065391

Type
ANDA
Sponsor
WOCKHARDT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFTRIAXONECEFTRIAXONE SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 250MG BASE/VIALNoNo
002CEFTRIAXONECEFTRIAXONE SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 500MG BASE/VIALNoNo
003CEFTRIAXONECEFTRIAXONE SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 2GM BASE/VIALNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065391-001CEFTRIAXONECEFTRIAXONE SODIUMEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12
A065391-002CEFTRIAXONECEFTRIAXONE SODIUMEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12
A065391-003CEFTRIAXONECEFTRIAXONE SODIUMEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A065391-001AP
A065391-002AP
A065391-003AP

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065391-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065391-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065391-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065391-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065391-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065391-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A065391-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065391-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065391-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065391-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065391-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065391-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065391-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065391-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065391-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065391-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065391-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065391-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065391-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065391-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065391-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065391-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065391-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065391-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065391-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065391-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065391-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065391-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A065391-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A065391-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065391-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065391-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065391-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065391-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065391-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065391-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065391-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065391-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065391-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065391-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2007-04-128072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065391-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065391-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065391-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065391-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065391-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065391-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065391-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065391-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065391-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065391-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065391-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065391-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065391-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065391-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065391-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065391-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065391-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065391-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065391-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065391-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065391-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065391-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065391-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065391-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065391-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065391-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065391-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065391-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065391-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065391-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065391-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065391-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065391-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065391-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065391-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065391-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065391-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065391-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065391-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065391-001AP18072bd15b7f6…

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 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ceftriaxone SodiumCEFTRIAXONE SODIUMSportpharm LLCddbc3bf6-5bab-4851-ae5a-ef263cd8f2552026-07-23Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
CeftriaxoneCEFTRIAXONEWG Critical Care, LLC86ec0a92-a552-4a6d-9125-a54f95e433922026-06-18Warnings, Adverse reactionsName fallback
brand name: Ceftriaxone
Ceftriaxone SodiumCEFTRIAXONE SODIUMSportpharm LLC85ce4f8b-77e0-48bf-9f57-93f1478befa22026-04-24Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMSportpharm LLC9a937e47-8c36-4656-83e1-b3c18ed9bac32026-04-24Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMREMEDYREPACK INC.9c801096-ca61-4b29-a1e1-5f7e7813b1912026-02-06Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMQilu Pharmaceutical Co., Ltd.4cdf0743-c62b-4969-b9c9-4c6400644f6c2026-02-04Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMHospira, Inc128bb292-d174-4769-b3e6-9f16617f31e32026-01-22Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMHospira, Inc19141ccd-e66c-49a2-a794-0616028495a72026-01-19Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMHospira, Inc03283208-8616-4117-9d2b-aa8046017a4f2026-01-19Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMHospira, Inc365fc265-8e6c-432f-9fda-911f5f7fb4512026-01-16Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMHospira, Inc36c07ebf-b091-483e-b2c4-f0fc0c2b41862026-01-16Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
CeftriaxoneCEFTRIAXONEWG Critical Care, LLC7bed9b33-29e3-4f04-9766-43a21c7ad47a2026-01-07Warnings, Adverse reactionsName fallback
brand name: Ceftriaxone
CeftriaxoneCEFTRIAXONEWG Critical Care, LLCbefd73ff-cb3b-4543-8a8e-bdb9b7fc1ff02025-04-07Warnings, Adverse reactionsName fallback
brand name: Ceftriaxone
Ceftriaxone SodiumCEFTRIAXONE SODIUMSandoz Inc53df951b-2eee-44b1-bae2-df7ed85bc0ed2025-02-28Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMSandoz Incde028434-46cf-44f6-8ac6-889c7c6943b32025-02-27Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
CeftriaxoneCEFTRIAXONE SODIUMBaxter Healthcare Company4c5c2d3f-5038-41a1-a2fe-4dcd048dbac12024-10-07Warnings, Adverse reactionsName fallback
brand name: Ceftriaxone
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMA-S Medication Solutions53415af6-4072-4339-83e2-d870ae02a0e22024-08-20Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
Ceftriaxone SodiumCEFTRIAXONE SODIUMA-S Medication Solutionsb642877e-0d36-4218-afe9-0a39f35b571d2024-03-27Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM
CeftriaxoneCEFTRIAXONECivica, Inc.96f3fc1e-84f4-4e9b-91ac-19a1692f227a2024-02-06Warnings, Adverse reactionsName fallback
brand name: Ceftriaxone
Ceftriaxone SodiumCEFTRIAXONE SODIUMProficient Rx LP790279d4-2456-4091-abec-960b788854322024-02-01Warnings, Adverse reactionsName fallback
generic name: CEFTRIAXONE SODIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42254-152CEFTRIAXONECEFTRIAXONERebel Distributors CorpANDACurrent
42254-191CEFTRIAXONECEFTRIAXONERebel Distributors CorpANDACurrent
55648-701CEFTRIAXONECEFTRIAXONEWockhardt LimitedANDACurrent
55648-702CEFTRIAXONECEFTRIAXONEWockhardt LimitedANDACurrent
55648-703CEFTRIAXONECEFTRIAXONEWockhardt LimitedANDACurrent
64679-701CEFTRIAXONECEFTRIAXONEWockhardt USA LLC.ANDACurrent
64679-701CEFTRIAXONECEFTRIAXONEWockhardt USA LLC.ANDACurrent
64679-701CEFTRIAXONECEFTRIAXONEWockhardt USA LLC.ANDACurrent
64679-702CEFTRIAXONECEFTRIAXONEWockhardt USA LLC.ANDACurrent
64679-702CEFTRIAXONECEFTRIAXONEWockhardt USA LLC.ANDACurrent
64679-702CEFTRIAXONECEFTRIAXONEWockhardt USA LLC.ANDACurrent
64679-703CEFTRIAXONECEFTRIAXONEWockhardt USA LLC.ANDACurrent
64679-703CEFTRIAXONECEFTRIAXONEWockhardt USA LLC.ANDACurrent
64679-703CEFTRIAXONECEFTRIAXONEWockhardt USA LLC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44236ORIG2008-09-19