Application 090940

Type: ANDA
Sponsor: HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEROPENEM	MEROPENEM	INJECTABLE;INJECTION	500MG/VIAL	No	No
002	MEROPENEM	MEROPENEM	INJECTABLE;INJECTION	1GM/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090940-001	MEROPENEM	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION			2010-06-22
A090940-002	MEROPENEM	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION			2010-06-22

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090940-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2010-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090940-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2010-06-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090940-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2010-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090940-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2010-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090940-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2010-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090940-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2010-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090940-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2010-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090940-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2010-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090940-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2010-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090940-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2010-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090940-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2010-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090940-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2010-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090940-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2010-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090940-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2010-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090940-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2010-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090940-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2010-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090940-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2010-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090940-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2010-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090940-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2010-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090940-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2010-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090940-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2010-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090940-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2010-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090940-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2010-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090940-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2010-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090940-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2010-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090940-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2010-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090940-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2010-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090940-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2010-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090940-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2010-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090940-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2010-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090940-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2010-06-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090940-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2010-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090940-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2010-06-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090940-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2010-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090940-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2010-06-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090940-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2010-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090940-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2010-06-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090940-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2010-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090940-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	2010-06-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090940-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	2010-06-22	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A090940-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090940-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090940-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090940-002	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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meropenem	MEROPENEM	Fresenius Kabi USA, LLC	12714f80-d6e5-4453-b66c-62f57c16ddfc	2021-03-12	Warnings, Adverse reactions	Name fallback brand name: Meropenem generic name: MEROPENEM
Meropenem	MEROPENEM	Fresenius Kabi USA, LLC	7a68d899-2678-43a9-a9c1-ef8f916b562f	2021-03-10	Warnings, Adverse reactions	Name fallback brand name: Meropenem generic name: MEROPENEM
Meropenem	MEROPENEM	Fresenius Kabi USA, LLC	185181e3-c004-4d61-b992-5df94fe57a90	2020-10-19	Warnings, Adverse reactions	Name fallback brand name: Meropenem generic name: MEROPENEM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-3505	Meropenem	MEROPENEM	Hospira, Inc.	ANDA	Current
0409-3505	Meropenem	MEROPENEM	Hospira, Inc.	ANDA	Current
0409-3505	Meropenem	MEROPENEM	Hospira, Inc.	ANDA	Current
0409-3506	Meropenem	MEROPENEM	Hospira, Inc.	ANDA	Current
0409-3506	Meropenem	MEROPENEM	Hospira, Inc.	ANDA	Current
0409-3506	Meropenem	MEROPENEM	Hospira, Inc.	ANDA	Current