Home Applications 091117 Application 091117
Type ANDA
Sponsor ASTRAL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CEFTRIAXONE SODIUM CEFTRIAXONE SODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091117-001 CEFTRIAXONE SODIUM CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091117-001 AP
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 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091117-001 CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2017-01-20 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 · 25 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ceftriaxone Sodium CEFTRIAXONE SODIUM Sportpharm LLC ddbc3bf6-5bab-4851-ae5a-ef263cd8f255 2026-07-23 Warnings, Adverse reactions Name fallback brand name: Ceftriaxone Sodium generic name: CEFTRIAXONE SODIUM Ceftriaxone Sodium CEFTRIAXONE SODIUM Sportpharm LLC 85ce4f8b-77e0-48bf-9f57-93f1478befa2 2026-04-24 Warnings, Adverse reactions Name fallback brand name: Ceftriaxone Sodium generic name: CEFTRIAXONE SODIUM Ceftriaxone Sodium CEFTRIAXONE SODIUM Sportpharm LLC 9a937e47-8c36-4656-83e1-b3c18ed9bac3 2026-04-24 Warnings, Adverse reactions Name fallback brand name: Ceftriaxone Sodium generic name: CEFTRIAXONE SODIUM Ceftriaxone Sodium CEFTRIAXONE SODIUM REMEDYREPACK INC. 9c801096-ca61-4b29-a1e1-5f7e7813b191 2026-02-06 Warnings, Adverse reactions Name fallback brand name: Ceftriaxone Sodium generic name: CEFTRIAXONE SODIUM Ceftriaxone Sodium CEFTRIAXONE SODIUM Qilu Pharmaceutical Co., Ltd. 4cdf0743-c62b-4969-b9c9-4c6400644f6c 2026-02-04 Warnings, Adverse reactions Name fallback brand name: Ceftriaxone Sodium generic name: CEFTRIAXONE SODIUM Ceftriaxone Sodium CEFTRIAXONE SODIUM Hospira, Inc 128bb292-d174-4769-b3e6-9f16617f31e3 2026-01-22 Warnings, Adverse reactions Name fallback brand name: Ceftriaxone Sodium generic name: CEFTRIAXONE SODIUM Ceftriaxone Sodium CEFTRIAXONE SODIUM Hospira, Inc 19141ccd-e66c-49a2-a794-0616028495a7 2026-01-19 Warnings, Adverse reactions Name fallback brand name: Ceftriaxone Sodium generic name: CEFTRIAXONE SODIUM Ceftriaxone Sodium CEFTRIAXONE SODIUM Hospira, Inc 03283208-8616-4117-9d2b-aa8046017a4f 2026-01-19 Warnings, Adverse reactions Name fallback brand name: Ceftriaxone Sodium generic name: CEFTRIAXONE SODIUM Ceftriaxone Sodium CEFTRIAXONE SODIUM Hospira, Inc 365fc265-8e6c-432f-9fda-911f5f7fb451 2026-01-16 Warnings, Adverse reactions Name fallback brand name: Ceftriaxone Sodium generic name: CEFTRIAXONE SODIUM Ceftriaxone Sodium CEFTRIAXONE SODIUM Hospira, Inc 36c07ebf-b091-483e-b2c4-f0fc0c2b4186 2026-01-16 Warnings, Adverse reactions Name fallback brand name: Ceftriaxone Sodium generic name: CEFTRIAXONE SODIUM Ceftriaxone Sodium CEFTRIAXONE SODIUM Sandoz Inc 53df951b-2eee-44b1-bae2-df7ed85bc0ed 2025-02-28 Warnings, Adverse reactions Name fallback brand name: Ceftriaxone Sodium generic name: CEFTRIAXONE SODIUM Ceftriaxone Sodium CEFTRIAXONE SODIUM Sandoz Inc de028434-46cf-44f6-8ac6-889c7c6943b3 2025-02-27 Warnings, Adverse reactions Name fallback brand name: Ceftriaxone Sodium generic name: CEFTRIAXONE SODIUM Ceftriaxone CEFTRIAXONE SODIUM Baxter Healthcare Company 4c5c2d3f-5038-41a1-a2fe-4dcd048dbac1 2024-10-07 Warnings, Adverse reactions Name fallback generic name: CEFTRIAXONE SODIUM Ceftriaxone Sodium CEFTRIAXONE SODIUM A-S Medication Solutions 53415af6-4072-4339-83e2-d870ae02a0e2 2024-08-20 Warnings, Adverse reactions Name fallback brand name: Ceftriaxone Sodium generic name: CEFTRIAXONE SODIUM Ceftriaxone Sodium CEFTRIAXONE SODIUM A-S Medication Solutions b642877e-0d36-4218-afe9-0a39f35b571d 2024-03-27 Warnings, Adverse reactions Name fallback brand name: Ceftriaxone Sodium generic name: CEFTRIAXONE SODIUM Ceftriaxone Sodium CEFTRIAXONE SODIUM Proficient Rx LP 790279d4-2456-4091-abec-960b78885432 2024-02-01 Warnings, Adverse reactions Name fallback brand name: Ceftriaxone Sodium generic name: CEFTRIAXONE SODIUM Ceftriaxone Sodium CEFTRIAXONE SODIUM A-S Medication Solutions 1aa0a4ee-1b39-4c3d-a7a3-33dded6fe28c 2024-01-31 Warnings, Adverse reactions Name fallback brand name: Ceftriaxone Sodium generic name: CEFTRIAXONE SODIUM Ceftriaxone Sodium CEFTRIAXONE SODIUM A-S Medication Solutions ff8e830a-c288-46fb-9e19-ec2017943c07 2024-01-31 Warnings, Adverse reactions Name fallback brand name: Ceftriaxone Sodium generic name: CEFTRIAXONE SODIUM Ceftriaxone Sodium CEFTRIAXONE SODIUM Asclemed USA, Inc. f01cf0e5-caaf-4759-ba21-50f3aceff523 2023-09-02 Warnings, Adverse reactions Name fallback brand name: Ceftriaxone Sodium generic name: CEFTRIAXONE SODIUM Ceftriaxone Sodium CEFTRIAXONE SODIUM Apotex Corp. 5116231f-82d1-44be-b08e-560c9a50e5c5 2023-08-31 Warnings, Adverse reactions Name fallback brand name: Ceftriaxone Sodium generic name: CEFTRIAXONE SODIUM
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66794-215 Ceftriaxone Ceftriaxone Piramal Critical Care Inc ANDA Current 66794-215 Ceftriaxone Ceftriaxone Piramal Critical Care Inc ANDA Current 66794-215 Ceftriaxone Ceftriaxone Piramal Critical Care Inc ANDA Current 66794-215 Ceftriaxone Ceftriaxone Piramal Critical Care Inc ANDA Current 66794-215 Ceftriaxone Ceftriaxone Piramal Critical Care Inc ANDA Current 66794-215 Ceftriaxone Ceftriaxone Piramal Critical Care Inc ANDA Current 70594-098 Ceftriaxone Ceftriaxone Xellia Pharmaceuticals USA LLC ANDA Current