Application 065141

Type: ANDA
Sponsor: SAMSON MEDCL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 100GM BASE/VIAL	No	Yes
002	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 300GM BASE/VIAL	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A065141-001	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION		RS	2006-11-29
A065141-002	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION		RS	2006-11-29

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A065141-001	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065141-002	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065141-001	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065141-002	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065141-001	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065141-002	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065141-001	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065141-002	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065141-001	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065141-002	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065141-001	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065141-002	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065141-001	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065141-002	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065141-001	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065141-002	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065141-001	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065141-002	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065141-001	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065141-002	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065141-001	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065141-002	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065141-001	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065141-002	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065141-001	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065141-002	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065141-001	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065141-002	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065141-001	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065141-002	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065141-001	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065141-002	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065141-001	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065141-002	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065141-001	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065141-002	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065141-001	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065141-002	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065141-001	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065141-002	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE / INJECTION	RS	2006-11-29	`bb7c543d1eb4…`

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
CEFAZOLIN	CEFAZOLIN SODIUM	Samson Medical Technologies, L.L.C.	cf13db9c-d8a1-489f-9aa0-fc70839d4bbc	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065141 application number: ANDA065141 ndc (product): 66288-1300 ndc (product): 66288-1100

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66288-1100	CEFAZOLIN	CEFAZOLIN SODIUM	Samson Medical Technologies, L.L.C.	ANDA	Current
66288-1100	CEFAZOLIN	CEFAZOLIN SODIUM	Samson Medical Technologies, L.L.C.	ANDA	Current
66288-1100	CEFAZOLIN	CEFAZOLIN SODIUM	Samson Medical Technologies, L.L.C.	ANDA	Current
66288-1100	CEFAZOLIN	CEFAZOLIN SODIUM	Samson Medical Technologies, L.L.C.	ANDA	Current
66288-1300	CEFAZOLIN	CEFAZOLIN SODIUM	Samson Medical Technologies, L.L.C.	ANDA	Current
66288-1300	CEFAZOLIN	CEFAZOLIN SODIUM	Samson Medical Technologies, L.L.C.	ANDA	Current
66288-1300	CEFAZOLIN	CEFAZOLIN SODIUM	Samson Medical Technologies, L.L.C.	ANDA	Current
66288-1300	CEFAZOLIN	CEFAZOLIN SODIUM	Samson Medical Technologies, L.L.C.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30654	SUPPL	2014-02-26
39418	SUPPL	2014-02-06