Application 065224

Type: ANDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFTRIAXONE IN PLASTIC CONTAINER	CEFTRIAXONE SODIUM	INJECTABLE;INJECTION	EQ 20MG BASE/ML	No	Yes
002	CEFTRIAXONE IN PLASTIC CONTAINER	CEFTRIAXONE SODIUM	INJECTABLE;INJECTION	EQ 40MG BASE/ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	CEFTRIAXONE SODIUM	EQ 20MG BASE/ML	INJECTABLE / INJECTION		RS	2005-08-23
A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	CEFTRIAXONE SODIUM	EQ 40MG BASE/ML	INJECTABLE / INJECTION		RS	2005-08-23

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065224-001	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065224-002	CEFTRIAXONE IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RS	2005-08-23	`3a93d1ddd44b…`

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	Baxter Healthcare Company	4c5c2d3f-5038-41a1-a2fe-4dcd048dbac1	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065224 application number: ANDA065224 ndc (product): 0338-5003 ndc (product): 0338-5002

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-5002	Ceftriaxone	Ceftriaxone Sodium	Baxter Healthcare Corporation	ANDA	Current
0338-5002	Ceftriaxone	Ceftriaxone Sodium	Baxter Healthcare Corporation	ANDA	Current
0338-5002	Ceftriaxone	Ceftriaxone Sodium	Baxter Healthcare Corporation	ANDA	Current
0338-5002	Ceftriaxone	Ceftriaxone Sodium	Baxter Healthcare Corporation	ANDA	Current
0338-5002	Ceftriaxone	Ceftriaxone Sodium	Baxter Healthcare Corporation	ANDA	Current
0338-5003	Ceftriaxone	Ceftriaxone Sodium	Baxter Healthcare Corporation	ANDA	Current
0338-5003	Ceftriaxone	Ceftriaxone Sodium	Baxter Healthcare Corporation	ANDA	Current
0338-5003	Ceftriaxone	Ceftriaxone Sodium	Baxter Healthcare Corporation	ANDA	Current
0338-5003	Ceftriaxone	Ceftriaxone Sodium	Baxter Healthcare Corporation	ANDA	Current
0338-5003	Ceftriaxone	Ceftriaxone Sodium	Baxter Healthcare Corporation	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23739	ORIG	2008-09-19