Application 062640

Type: ANDA
Sponsor: ACS DOBFAR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFTAZIDIME	CEFTAZIDIME	INJECTABLE;INJECTION	500MG/VIAL	No	No
002	CEFTAZIDIME	CEFTAZIDIME	INJECTABLE;INJECTION	1GM/VIAL	No	No
003	CEFTAZIDIME	CEFTAZIDIME	INJECTABLE;INJECTION	2GM/VIAL	No	No
004	CEFTAZIDIME	CEFTAZIDIME	INJECTABLE;INJECTION	6GM/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062640-001	CEFTAZIDIME	CEFTAZIDIME	500MG/VIAL	INJECTABLE / INJECTION			1985-11-20
A062640-002	CEFTAZIDIME	CEFTAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20
A062640-003	CEFTAZIDIME	CEFTAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20
A062640-004	CEFTAZIDIME	CEFTAZIDIME	6GM/VIAL	INJECTABLE / INJECTION	AP	RS	1992-02-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A062640-002	AP
A062640-003	AP
A062640-004	AP

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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	A062640-001	CEFTAZIDIME	500MG/VIAL	INJECTABLE / INJECTION			1985-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062640-002	CEFTAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062640-003	CEFTAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062640-004	CEFTAZIDIME	6GM/VIAL	INJECTABLE / INJECTION	AP	RS	1992-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062640-001	CEFTAZIDIME	500MG/VIAL	INJECTABLE / INJECTION			1985-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062640-002	CEFTAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062640-003	CEFTAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062640-004	CEFTAZIDIME	6GM/VIAL	INJECTABLE / INJECTION	AP	RS	1992-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062640-001	CEFTAZIDIME	500MG/VIAL	INJECTABLE / INJECTION			1985-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062640-002	CEFTAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062640-003	CEFTAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062640-004	CEFTAZIDIME	6GM/VIAL	INJECTABLE / INJECTION	AP	RS	1992-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062640-001	CEFTAZIDIME	500MG/VIAL	INJECTABLE / INJECTION			1985-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062640-002	CEFTAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062640-003	CEFTAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062640-004	CEFTAZIDIME	6GM/VIAL	INJECTABLE / INJECTION	AP	RS	1992-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062640-001	CEFTAZIDIME	500MG/VIAL	INJECTABLE / INJECTION			1985-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062640-002	CEFTAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062640-003	CEFTAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062640-004	CEFTAZIDIME	6GM/VIAL	INJECTABLE / INJECTION	AP	RS	1992-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062640-001	CEFTAZIDIME	500MG/VIAL	INJECTABLE / INJECTION			1985-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062640-002	CEFTAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062640-003	CEFTAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062640-004	CEFTAZIDIME	6GM/VIAL	INJECTABLE / INJECTION	AP	RS	1992-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062640-001	CEFTAZIDIME	500MG/VIAL	INJECTABLE / INJECTION			1985-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062640-002	CEFTAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062640-003	CEFTAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062640-004	CEFTAZIDIME	6GM/VIAL	INJECTABLE / INJECTION	AP	RS	1992-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062640-001	CEFTAZIDIME	500MG/VIAL	INJECTABLE / INJECTION			1985-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062640-002	CEFTAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062640-003	CEFTAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062640-004	CEFTAZIDIME	6GM/VIAL	INJECTABLE / INJECTION	AP	RS	1992-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062640-001	CEFTAZIDIME	500MG/VIAL	INJECTABLE / INJECTION			1985-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062640-002	CEFTAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062640-003	CEFTAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062640-004	CEFTAZIDIME	6GM/VIAL	INJECTABLE / INJECTION	AP	RS	1992-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062640-001	CEFTAZIDIME	500MG/VIAL	INJECTABLE / INJECTION			1985-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062640-002	CEFTAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062640-003	CEFTAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	AP	RS	1985-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062640-004	CEFTAZIDIME	6GM/VIAL	INJECTABLE / INJECTION	AP	RS	1992-02-03	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062640-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062640-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062640-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062640-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062640-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062640-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062640-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062640-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062640-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062640-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062640-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062640-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062640-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062640-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062640-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062640-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062640-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062640-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062640-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062640-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062640-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062640-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062640-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062640-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062640-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062640-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062640-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062640-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062640-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062640-004	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062640-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062640-003	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062640-004	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062640-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062640-003	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062640-004	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062640-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062640-003	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062640-004	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062640-002	AP	1	`8072bd15b7f6…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ceftazidime	CEFTAZIDIME	WG Critical Care, LLC	22d6534c-4488-48a1-8d78-e2fb908259de	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062640 application number: ANDA062640 ndc (product): 44567-237
Ceftazidime	CEFTAZIDIME	Sagent Pharmaceuticals	aec64360-8452-4987-a366-a5a4f8762ab6	2024-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062640 application number: ANDA062640 ndc (product): 25021-129
Ceftazidime	CEFTAZIDIME	WG Critical Care, LLC	bcc81df2-20e3-4738-bfcf-301da883c1d9	2023-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062640 application number: ANDA062640 ndc (product): 44567-236 ndc (product): 44567-235
Ceftazidime	CEFTAZIDIME	Sagent Pharmaceuticals	112c5457-8d71-49f5-b531-9761d7d38c93	2020-10-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062640 application number: ANDA062640 ndc (product): 25021-127 ndc (product): 25021-128

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-3177	Ceftazidime	Ceftazidime	Sandoz Inc	ANDA	Current
0781-3178	Ceftazidime	Ceftazidime	Sandoz Inc	ANDA	Current
0781-3179	Ceftazidime	Ceftazidime	Sandoz Inc	ANDA	Current
25021-127	Ceftazidime	ceftazidime	Sagent Pharmaceuticals	ANDA	Current
25021-127	Ceftazidime	ceftazidime	Sagent Pharmaceuticals	ANDA	Current
25021-127	Ceftazidime	ceftazidime	Sagent Pharmaceuticals	ANDA	Current
25021-127	Ceftazidime	ceftazidime	Sagent Pharmaceuticals	ANDA	Current
25021-127	Ceftazidime	ceftazidime	Sagent Pharmaceuticals	ANDA	Current
25021-127	Ceftazidime	ceftazidime	Sagent Pharmaceuticals	ANDA	Current
25021-128	Ceftazidime	ceftazidime	Sagent Pharmaceuticals	ANDA	Current
25021-128	Ceftazidime	ceftazidime	Sagent Pharmaceuticals	ANDA	Current
25021-128	Ceftazidime	ceftazidime	Sagent Pharmaceuticals	ANDA	Current
25021-128	Ceftazidime	ceftazidime	Sagent Pharmaceuticals	ANDA	Current
25021-128	Ceftazidime	ceftazidime	Sagent Pharmaceuticals	ANDA	Current
25021-128	Ceftazidime	ceftazidime	Sagent Pharmaceuticals	ANDA	Current
25021-128	Ceftazidime	ceftazidime	Sagent Pharmaceuticals	ANDA	Current
25021-129	Ceftazidime	ceftazidime	Sagent Pharmaceuticals	ANDA	Current
25021-129	Ceftazidime	ceftazidime	Sagent Pharmaceuticals	ANDA	Current
25021-129	Ceftazidime	ceftazidime	Sagent Pharmaceuticals	ANDA	Current
25021-129	Ceftazidime	ceftazidime	Sagent Pharmaceuticals	ANDA	Current
25021-129	Ceftazidime	ceftazidime	Sagent Pharmaceuticals	ANDA	Current
25021-129	Ceftazidime	ceftazidime	Sagent Pharmaceuticals	ANDA	Current
44567-235	Ceftazidime	Ceftazidime	WG Critical Care, LLC	ANDA	Current
44567-235	Ceftazidime	Ceftazidime	WG Critical Care, LLC	ANDA	Current
44567-235	Ceftazidime	Ceftazidime	WG Critical Care, LLC	ANDA	Current
44567-235	Ceftazidime	Ceftazidime	WG Critical Care, LLC	ANDA	Current
44567-235	Ceftazidime	Ceftazidime	WG Critical Care, LLC	ANDA	Current
44567-236	Ceftazidime	Ceftazidime	WG Critical Care, LLC	ANDA	Current
44567-236	Ceftazidime	Ceftazidime	WG Critical Care, LLC	ANDA	Current
44567-236	Ceftazidime	Ceftazidime	WG Critical Care, LLC	ANDA	Current
44567-236	Ceftazidime	Ceftazidime	WG Critical Care, LLC	ANDA	Current
44567-236	Ceftazidime	Ceftazidime	WG Critical Care, LLC	ANDA	Current
44567-237	Ceftazidime	Ceftazidime	WG Critical Care, LLC	ANDA	Current
44567-237	Ceftazidime	Ceftazidime	WG Critical Care, LLC	ANDA	Current
44567-237	Ceftazidime	Ceftazidime	WG Critical Care, LLC	ANDA	Current
44567-237	Ceftazidime	Ceftazidime	WG Critical Care, LLC	ANDA	Current
44567-237	Ceftazidime	Ceftazidime	WG Critical Care, LLC	ANDA	Current