Application 063002

Type: ANDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ANCEF IN PLASTIC CONTAINER	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 10MG BASE/ML	No	No
002	ANCEF IN PLASTIC CONTAINER	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 20MG 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
A063002-001	ANCEF IN PLASTIC CONTAINER	CEFAZOLIN SODIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION			1991-03-28
A063002-002	ANCEF IN PLASTIC CONTAINER	CEFAZOLIN SODIUM	EQ 20MG BASE/ML	INJECTABLE / INJECTION			1991-03-28

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	A063002-001	ANCEF IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A063002-002	ANCEF IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	1991-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063002-001	ANCEF IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A063002-002	ANCEF IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	1991-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063002-001	ANCEF IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A063002-002	ANCEF IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	1991-03-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063002-001	ANCEF IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063002-002	ANCEF IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	1991-03-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063002-001	ANCEF IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A063002-002	ANCEF IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	1991-03-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063002-001	ANCEF IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A063002-002	ANCEF IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	1991-03-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063002-001	ANCEF IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A063002-002	ANCEF IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	1991-03-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063002-001	ANCEF IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A063002-002	ANCEF IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	1991-03-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063002-001	ANCEF IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A063002-002	ANCEF IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	1991-03-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063002-001	ANCEF IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A063002-002	ANCEF IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	1991-03-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A063002-001	ANCEF IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A063002-002	ANCEF IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A063002-001	ANCEF IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A063002-002	ANCEF IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A063002-001	ANCEF IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A063002-002	ANCEF IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063002-001	ANCEF IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063002-002	ANCEF IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A063002-001	ANCEF IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A063002-002	ANCEF IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	1991-03-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A063002-001	ANCEF IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A063002-002	ANCEF IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	1991-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A063002-001	ANCEF IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A063002-002	ANCEF IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	1991-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A063002-001	ANCEF IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A063002-002	ANCEF IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	1991-03-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A063002-001	ANCEF IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A063002-002	ANCEF IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	1991-03-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063002-001	ANCEF IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1991-03-28	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063002-002	ANCEF IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RS	1991-03-28	`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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefazolin Sodium	CEFAZOLIN SODIUM	B. Braun Medical Inc.	17f8f038-c204-4dab-80d7-6f7ac41ddbec	2025-03-10	Warnings, Adverse reactions	Name fallback generic name: CEFAZOLIN SODIUM
CEFAZOLIN	CEFAZOLIN SODIUM	Samson Medical Technologies, L.L.C.	cf13db9c-d8a1-489f-9aa0-fc70839d4bbc	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: CEFAZOLIN SODIUM
Cefazolin Sodium	CEFAZOLIN SODIUM	Direct_rx	22dfc2e4-07a7-8d13-e063-6394a90a3e9f	2024-09-24	Warnings, Adverse reactions	Name fallback generic name: CEFAZOLIN SODIUM
CEFAZOLIN	CEFAZOLIN SODIUM	Fresenius Kabi USA, LLC	c47c8d14-1eef-40f9-9d11-f0c300b1d4be	2023-09-27	Warnings, Adverse reactions	Name fallback generic name: CEFAZOLIN SODIUM
Cefazolin	CEFAZOLIN SODIUM	Fresenius Kabi USA, LLC	47a8928f-708d-418a-829b-36eded96bac0	2020-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CEFAZOLIN SODIUM

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-3503	Cefazolin	Cefazolin Sodium	Baxter Healthcare Corporation	ANDA	Current
0338-3503	Cefazolin	Cefazolin Sodium	Baxter Healthcare Corporation	ANDA	Current
0338-3503	Cefazolin	Cefazolin Sodium	Baxter Healthcare Corporation	ANDA	Current
0338-3503	Cefazolin	Cefazolin Sodium	Baxter Healthcare Corporation	ANDA	Current
0338-3503	Cefazolin	Cefazolin Sodium	Baxter Healthcare Corporation	ANDA	Current