Application 203702

Type
ANDA
Sponsor
QILU

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 1GM BASE/VIALNoNo
004CEFTRIAXONECEFTRIAXONE SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 2GM BASE/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203702-001CEFTRIAXONECEFTRIAXONE SODIUMEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29
A203702-002CEFTRIAXONECEFTRIAXONE SODIUMEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29
A203702-003CEFTRIAXONECEFTRIAXONE SODIUMEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29
A203702-004CEFTRIAXONECEFTRIAXONE SODIUMEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A203702-001AP
A203702-002AP
A203702-003AP
A203702-004AP

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-001CEFTRIAXONEEQ 250MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-002CEFTRIAXONEEQ 500MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-003CEFTRIAXONEEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-004CEFTRIAXONEEQ 2GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAP2016-06-29d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203702-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A203702-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A203702-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A203702-004AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203702-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203702-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203702-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203702-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203702-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203702-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203702-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203702-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203702-004AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203702-004AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203702-004AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203702-004AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203702-004AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203702-004AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203702-004AP1d8e5a09893c0…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ceftriaxone SodiumCEFTRIAXONE SODIUMSportpharm LLC85ce4f8b-77e0-48bf-9f57-93f1478befa22026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
Ceftriaxone SodiumCEFTRIAXONE SODIUMSportpharm LLC9a937e47-8c36-4656-83e1-b3c18ed9bac32026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
Ceftriaxone SodiumCEFTRIAXONE SODIUMQilu Pharmaceutical Co., Ltd.4cdf0743-c62b-4969-b9c9-4c6400644f6c2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
ndc (product): 67184-1005
ndc (product): 67184-1006
ndc (product): 67184-1008
ndc (product): 67184-1007
Ceftriaxone SodiumCEFTRIAXONE SODIUMA-S Medication Solutions53415af6-4072-4339-83e2-d870ae02a0e22024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
ndc (product): 50090-3838
Ceftriaxone SodiumCEFTRIAXONE SODIUMProficient Rx LP790279d4-2456-4091-abec-960b788854322024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
Ceftriaxone SodiumCEFTRIAXONE SODIUMAsclemed USA, Inc.f01cf0e5-caaf-4759-ba21-50f3aceff5232023-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
Ceftriaxone SodiumCEFTRIAXONE SODIUMApotex Corp.5116231f-82d1-44be-b08e-560c9a50e5c52023-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
ndc (product): 60505-6148
ndc (product): 60505-6151
ndc (product): 60505-6149
ndc (product): 60505-6152
Ceftriaxone SodiumCEFTRIAXONE SODIUMProficient Rx LP42ba7a9d-7d2b-4eac-af59-897151a8c9242022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203702
application number: ANDA203702
ndc (product): 71205-545

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3810Ceftriaxone SodiumCeftriaxone SodiumA-S Medication SolutionsANDACurrent
50090-3810Ceftriaxone SodiumCeftriaxone SodiumA-S Medication SolutionsANDACurrent
50090-3838Ceftriaxone SodiumCeftriaxone SodiumA-S Medication SolutionsANDACurrent
50090-3838Ceftriaxone SodiumCeftriaxone SodiumA-S Medication SolutionsANDACurrent
50090-4689Ceftriaxone SodiumCeftriaxone SodiumA-S Medication SolutionsANDACurrent
50090-4689Ceftriaxone SodiumCeftriaxone SodiumA-S Medication SolutionsANDACurrent
50090-4689Ceftriaxone SodiumCeftriaxone SodiumA-S Medication SolutionsANDACurrent
50090-4978Ceftriaxone SodiumCeftriaxone SodiumA-S Medication SolutionsANDACurrent
50090-4978Ceftriaxone SodiumCeftriaxone SodiumA-S Medication SolutionsANDACurrent
52584-148CeftriaxoneCeftriaxone SodiumGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-148CeftriaxoneCeftriaxone SodiumGeneral Injectables and Vaccines, Inc.ANDACurrent
60505-6148Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6148Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6148Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6148Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6148Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6148Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6149Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6149Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6149Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6149Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6149Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6149Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6151Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6151Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6151Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6151Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6151Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6151Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6152Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6152Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6152Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6152Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6152Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
60505-6152Ceftriaxone SodiumCeftriaxone SodiumApotex Corp.ANDACurrent
67184-1005Ceftriaxone SodiumCeftriaxone SodiumQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-1006Ceftriaxone SodiumCeftriaxone SodiumQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-1007Ceftriaxone SodiumCeftriaxone SodiumQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-1008Ceftriaxone SodiumCeftriaxone SodiumQilu Pharmaceutical Co., Ltd.ANDACurrent
70518-3099Ceftriaxone SodiumCeftriaxone SodiumREMEDYREPACK INC.ANDACurrent
71205-545Ceftriaxone SodiumCeftriaxone SodiumProficient Rx LPANDACurrent
71205-545Ceftriaxone SodiumCeftriaxone SodiumProficient Rx LPANDACurrent