Application 208790

Type: ANDA
Sponsor: ACS DOBFAR SPA

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
A208790-001	ERTAPENEM SODIUM	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP		2018-04-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208790-001	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.

Product history page 1 of 2 · 41 observed 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	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208790-001	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2018-04-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A208790-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208790-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208790-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208790-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208790-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208790-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208790-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208790-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208790-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208790-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208790-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208790-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208790-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208790-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208790-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208790-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208790-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208790-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208790-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208790-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208790-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208790-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208790-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208790-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208790-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208790-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208790-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208790-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208790-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208790-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208790-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208790-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208790-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208790-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208790-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208790-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208790-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208790-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208790-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208790-001	AP	1	`cb3db0bc1861…`

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 sodium	ERTAPENEM SODIUM	Hikma Pharmaceuticals USA, Inc.	a400707f-763f-43f6-989e-0d2569d822d8	2024-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208790 application number: ANDA208790 ndc (product): 0143-9398
Ertapenem	ERTAPENEM	Hospira, Inc.	178a0356-4f6c-47fb-9913-f325a3c72f7b	2024-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208790 application number: ANDA208790 ndc (product): 0409-3510
Ertapenem	ERTAPENEM SODIUM	Fresenius Kabi USA, LLC	666c9f33-ea9e-4667-b8bd-f8b1b6b6be51	2022-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208790 application number: ANDA208790 ndc (product): 63323-823
ertapenem	ERTAPENEM	WG Critical Care, LLC	cf3cfa6b-211c-452b-b18b-e462b21e6909	2022-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208790 application number: ANDA208790 ndc (product): 44567-820

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9398	ertapenem sodium	ertapenem sodium	Hikma Pharmaceuticals USA, Inc.	ANDA	Current
0409-3510	Ertapenem	Ertapenem	Hospira, Inc.	ANDA	Current
44567-820	ertapenem	ertapenem	WG Critical Care, LLC	ANDA	Current
44567-820	ertapenem	ertapenem	WG Critical Care, LLC	ANDA	Current
44567-820	ertapenem	ertapenem	WG Critical Care, LLC	ANDA	Current
44567-820	ertapenem sodium	ertapenem sodium	WG Critical Care, LLC	ANDA	Current
44567-820	ertapenem	ertapenem	WG Critical Care, LLC	ANDA	Current
44567-820	ertapenem sodium	ertapenem sodium	WG Critical Care, LLC	ANDA	Current
63323-823	Ertapenem	Ertapenem Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-823	Ertapenem	Ertapenem Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-823	Ertapenem	Ertapenem Sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-823	Ertapenem	Ertapenem Sodium	Fresenius Kabi USA, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54080	ORIG	2018-05-10