Application 065247

Type: ANDA
Sponsor: HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFAZOLIN SODIUM	CEFAZOLIN 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
A065247-001	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12

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	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-08-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-08-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-08-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2005-08-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065247-001	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2005-08-12	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A065247-001	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A065247-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065247-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065247-001	AP	1	`ea99ee380514…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefazolin	CEFAZOLIN SODIUM	Baxter Healthcare Corporation	d91a8d13-99a0-4d87-88dc-71cbd37922b4	2025-12-10	Warnings, Adverse reactions	Name fallback generic name: CEFAZOLIN SODIUM
Cefazolin Sodium	CEFAZOLIN SODIUM	B. Braun Medical Inc.	17f8f038-c204-4dab-80d7-6f7ac41ddbec	2025-03-10	Warnings, Adverse reactions	Name fallback brand name: Cefazolin Sodium 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 brand name: Cefazolin Sodium 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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-0806	Cefazolin	Cefazolin	Hospira, Inc.	ANDA	Current
60505-0769	Cefazolin	Cefazolin	Apotex Corporation	ANDA	Current
60505-0769	Cefazolin	Cefazolin	Apotex Corporation	ANDA	Current
60505-6094	Cefazolin	Cefazolin	Apotex Corporation	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39420	SUPPL	2014-02-06