Application 065329

Type
ANDA
Sponsor
ACS DOBFAR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFTRIAXONECEFTRIAXONE SODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo
002CEFTRIAXONECEFTRIAXONE SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
003CEFTRIAXONECEFTRIAXONE SODIUMINJECTABLE;INJECTIONEQ 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
A065329-001CEFTRIAXONECEFTRIAXONE SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-24
A065329-002CEFTRIAXONECEFTRIAXONE SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24
A065329-003CEFTRIAXONECEFTRIAXONE SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065329-001AP
A065329-002AP
A065329-003AP

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 UTC2026-02A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065329-002CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065329-003CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2008-07-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065329-001CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2008-07-248072bd15b7f6…

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 UTC2026-02A065329-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065329-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065329-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065329-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065329-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065329-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065329-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065329-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065329-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065329-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065329-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065329-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065329-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065329-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065329-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065329-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065329-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065329-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065329-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065329-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065329-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065329-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065329-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065329-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065329-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065329-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065329-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065329-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065329-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065329-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065329-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065329-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065329-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065329-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065329-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065329-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065329-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065329-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065329-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065329-001AP18072bd15b7f6…

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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CeftriaxoneCEFTRIAXONEWG Critical Care, LLC7bed9b33-29e3-4f04-9766-43a21c7ad47a2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065329
application number: ANDA065329
ndc (product): 44567-701
ndc (product): 44567-702
CeftriaxoneCEFTRIAXONEWG Critical Care, LLCbefd73ff-cb3b-4543-8a8e-bdb9b7fc1ff02025-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065329
application number: ANDA065329
ndc (product): 44567-701
ndc (product): 44567-700
ndc (product): 44567-702
ceftriaxoneCEFTRIAXONESagent Pharmaceuticals5cf93bc5-9e4c-4734-bc02-c7d0ac0710222023-11-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065329
application number: ANDA065329
ndc (product): 25021-107
ndc (product): 25021-105
ndc (product): 25021-106
CeftriaxoneCEFTRIAXONEFresenius Kabi USA, LLC7ea1db43-40fa-417b-8911-ae98092070a02023-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065329
application number: ANDA065329
ndc (product): 63323-346
ndc (product): 63323-347
CeftriaxoneCEFTRIAXONEProficient Rx LPfcf401df-bcdc-4773-a63b-9741c0f74b3d2022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065329
application number: ANDA065329
ndc (product): 71205-593

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 66 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-105CeftriaxoneCeftriaxoneSagent PharmaceuticalsANDACurrent
25021-105ceftriaxoneceftriaxoneSagent PharmaceuticalsANDACurrent
25021-105ceftriaxoneceftriaxoneSagent PharmaceuticalsANDACurrent
25021-105CeftriaxoneCeftriaxoneSagent PharmaceuticalsANDACurrent
25021-105CeftriaxoneCeftriaxoneSagent PharmaceuticalsANDACurrent
25021-105CeftriaxoneCeftriaxoneSagent PharmaceuticalsANDACurrent
25021-105CeftriaxoneCeftriaxoneSagent PharmaceuticalsANDACurrent
25021-105ceftriaxoneceftriaxoneSagent PharmaceuticalsANDACurrent
25021-105ceftriaxoneceftriaxoneSagent PharmaceuticalsANDACurrent
25021-105ceftriaxoneceftriaxoneSagent PharmaceuticalsANDACurrent
25021-105CeftriaxoneCeftriaxoneSagent PharmaceuticalsANDACurrent
25021-105ceftriaxoneceftriaxoneSagent PharmaceuticalsANDACurrent
25021-106CeftriaxoneCeftriaxoneSagent PharmaceuticalsANDACurrent
25021-106ceftriaxoneceftriaxoneSagent PharmaceuticalsANDACurrent
25021-106ceftriaxoneceftriaxoneSagent PharmaceuticalsANDACurrent
25021-106CeftriaxoneCeftriaxoneSagent PharmaceuticalsANDACurrent
25021-106CeftriaxoneCeftriaxoneSagent PharmaceuticalsANDACurrent
25021-106CeftriaxoneCeftriaxoneSagent PharmaceuticalsANDACurrent
25021-106CeftriaxoneCeftriaxoneSagent PharmaceuticalsANDACurrent
25021-106CeftriaxoneCeftriaxoneSagent PharmaceuticalsANDACurrent
25021-106ceftriaxoneceftriaxoneSagent PharmaceuticalsANDACurrent
25021-106ceftriaxoneceftriaxoneSagent PharmaceuticalsANDACurrent
25021-106ceftriaxoneceftriaxoneSagent PharmaceuticalsANDACurrent
25021-106CeftriaxoneCeftriaxoneSagent PharmaceuticalsANDACurrent
25021-106ceftriaxoneceftriaxoneSagent PharmaceuticalsANDACurrent
25021-107CeftriaxoneCeftriaxoneSagent PharmaceuticalsANDACurrent
25021-107ceftriaxoneceftriaxoneSagent PharmaceuticalsANDACurrent
25021-107ceftriaxoneceftriaxoneSagent PharmaceuticalsANDACurrent
25021-107CeftriaxoneCeftriaxoneSagent PharmaceuticalsANDACurrent
25021-107CeftriaxoneCeftriaxoneSagent PharmaceuticalsANDACurrent
25021-107CeftriaxoneCeftriaxoneSagent PharmaceuticalsANDACurrent
25021-107CeftriaxoneCeftriaxoneSagent PharmaceuticalsANDACurrent
25021-107CeftriaxoneCeftriaxoneSagent PharmaceuticalsANDACurrent
25021-107ceftriaxoneceftriaxoneSagent PharmaceuticalsANDACurrent
25021-107ceftriaxoneceftriaxoneSagent PharmaceuticalsANDACurrent
25021-107ceftriaxoneceftriaxoneSagent PharmaceuticalsANDACurrent
25021-107CeftriaxoneCeftriaxoneSagent PharmaceuticalsANDACurrent
25021-107ceftriaxoneceftriaxoneSagent PharmaceuticalsANDACurrent
44567-700CeftriaxoneCeftriaxoneWG Critical Care, LLCANDACurrent
44567-700CeftriaxoneCeftriaxoneWG Critical Care, LLCANDACurrent
44567-700CeftriaxoneCeftriaxoneWG Critical Care, LLCANDACurrent
44567-700CeftriaxoneCeftriaxoneWG Critical Care, LLCANDACurrent
44567-700CeftriaxoneCeftriaxoneWG Critical Care, LLCANDACurrent
44567-700CeftriaxoneCeftriaxoneWG Critical Care, LLCANDACurrent
44567-701CeftriaxoneCeftriaxoneWG Critical Care, LLCANDACurrent
44567-701CeftriaxoneCeftriaxoneWG Critical Care, LLCANDACurrent
44567-701CeftriaxoneCeftriaxoneWG Critical Care, LLCANDACurrent
44567-701CeftriaxoneCeftriaxoneWG Critical Care, LLCANDACurrent
44567-701CeftriaxoneCeftriaxoneWG Critical Care, LLCANDACurrent
44567-701CeftriaxoneCeftriaxoneWG Critical Care, LLCANDACurrent
44567-701CeftriaxoneCeftriaxoneWG Critical Care, LLCANDACurrent
44567-702CeftriaxoneCeftriaxoneWG Critical Care, LLCANDACurrent
44567-702CeftriaxoneCeftriaxoneWG Critical Care, LLCANDACurrent
44567-702CeftriaxoneCeftriaxoneWG Critical Care, LLCANDACurrent
44567-702CeftriaxoneCeftriaxoneWG Critical Care, LLCANDACurrent
44567-702CeftriaxoneCeftriaxoneWG Critical Care, LLCANDACurrent
44567-702CeftriaxoneCeftriaxoneWG Critical Care, LLCANDACurrent
44567-702CeftriaxoneCeftriaxoneWG Critical Care, LLCANDACurrent
63323-346CeftriaxoneCeftriaxoneFresenius Kabi USA, LLCANDACurrent
63323-346CeftriaxoneCeftriaxoneFresenius Kabi USA, LLCANDACurrent
63323-346CeftriaxoneCeftriaxoneFresenius Kabi USA, LLCANDACurrent
63323-347CeftriaxoneCeftriaxoneFresenius Kabi USA, LLCANDACurrent
63323-347CeftriaxoneCeftriaxoneFresenius Kabi USA, LLCANDACurrent
71205-593CeftriaxoneCeftriaxoneProficient Rx LPANDACurrent
71205-593CeftriaxoneCeftriaxoneProficient Rx LPANDACurrent
79144-101Easy-CeftCeftriaxoneAmerican Health RX, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44232ORIG2008-09-19