Application 090057

Type: ANDA
Sponsor: SAMSON MEDCL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFTRIAXONE	CEFTRIAXONE SODIUM	INJECTABLE;INJECTION	EQ 100GM 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
A090057-001	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION			2014-04-25

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090057-001	CEFTRIAXONE	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	2014-04-25	`e64feba35796…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ceftriaxone	CEFTRIAXONE SODIUM	Samson Medical Technologies, LLC	5cd2d96f-83e5-4326-ae87-d0ede4ba493a	2023-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090057 application number: ANDA090057 ndc (product): 66288-6100

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66288-6100	Ceftriaxone	Ceftriaxone Sodium	Samson Medical Technologies, LLC	ANDA	Current
66288-6100	Ceftriaxone	Ceftriaxone Sodium	Samson Medical Technologies, LLC	ANDA	Current
66288-6100	Ceftriaxone	Ceftriaxone Sodium	Samson Medical Technologies, LLC	ANDA	Current