Application 218067

Type: ANDA
Sponsor: QILU ANTIBIOTICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERTAPENEM SODIUM	ERTAPENEM SODIUM	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 1GM BASE/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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A218067-001	ERTAPENEM SODIUM	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP		2024-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218067-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A218067-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2024-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218067-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2024-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218067-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2024-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218067-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2024-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218067-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2024-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218067-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2024-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218067-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2024-10-31	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218067-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2024-10-31	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218067-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2024-10-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A218067-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218067-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218067-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218067-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218067-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218067-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218067-001	AP	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218067-001	AP	1	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218067-001	AP	1	`a50c72e98297…`

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
Ertapenem	ERTAPENEM SODIUM	Sagent Pharmaceuticals	124775ed-1271-4581-be52-b7a08c91283d	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218067 application number: ANDA218067
Ertapenem	ERTAPENEM SODIUM	Qilu Antibiotics Pharmaceutical Co., Ltd.	44496f7c-8407-4765-9cd6-1daa619a6db6	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218067 application number: ANDA218067
Ertapenem	ERTAPENEM SODIUM	Sagent Pharmaceuticals	39bd4d41-36f8-4826-a733-a5ad1a531c02	2025-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218067 application number: ANDA218067
Ertapenem	ERTAPENEM SODIUM	Hikma Pharmaceuticals USA Inc.	b88c0709-33fe-47db-8ae8-8bad6692d5d5	2024-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218067 application number: ANDA218067