Application 091404

Type: ANDA
Sponsor: ACS DOBFAR

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 1.

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
A091404-001	MEROPENEM	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2011-10-26
A091404-002	MEROPENEM	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	RS	2011-10-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091404-001	AP
A091404-002	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 3 · 82 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	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2011-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	RS	2011-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2011-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	RS	2011-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2011-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP	RS	2011-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091404-001	MEROPENEM	500MG/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091404-002	MEROPENEM	1GM/VIAL	INJECTABLE / INJECTION	AP		2011-10-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A091404-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091404-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091404-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091404-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091404-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091404-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091404-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091404-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091404-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091404-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091404-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091404-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091404-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091404-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091404-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091404-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091404-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091404-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091404-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091404-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091404-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091404-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091404-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091404-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091404-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091404-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091404-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091404-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091404-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091404-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091404-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091404-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091404-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091404-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091404-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091404-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091404-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091404-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091404-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091404-002	AP	1	`782e0a99824c…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meropenem	MEROPENEM	Hospira, Inc.	e9b6555f-20a1-4415-bb80-3d034cfab95b	2024-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091404 application number: ANDA091404 ndc (product): 0409-0222 ndc (product): 0409-3412
Meropenem	MEROPENEM	Hospira, Inc.	092ebd9b-77a0-4877-afc3-dd8211730f71	2024-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091404 application number: ANDA091404 ndc (product): 0409-1390 ndc (product): 0409-1391
Meropenem	MEROPENEM	Fresenius Kabi USA, LLC	12714f80-d6e5-4453-b66c-62f57c16ddfc	2021-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091404 application number: ANDA091404 ndc (product): 63323-508 ndc (product): 63323-507
Meropenem	MEROPENEM	Fresenius Kabi USA, LLC	7a68d899-2678-43a9-a9c1-ef8f916b562f	2021-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091404 application number: ANDA091404 ndc (product): 63323-508 ndc (product): 63323-507
Meropenem	MEROPENEM	Fresenius Kabi USA, LLC	185181e3-c004-4d61-b992-5df94fe57a90	2020-10-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091404 application number: ANDA091404 ndc (product): 63323-508 ndc (product): 63323-507

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-0222	Meropenem	Meropenem	Hospira, Inc.	ANDA	Current
0409-1390	Meropenem	Meropenem	Hospira, Inc.	ANDA	Current
0409-1390	Meropenem	Meropenem	Hospira, Inc.	ANDA	Current
0409-1390	Meropenem	Meropenem	Hospira, Inc.	ANDA	Current
0409-1390	Meropenem	Meropenem	Hospira, Inc.	ANDA	Current
0409-1391	Meropenem	Meropenem	Hospira, Inc.	ANDA	Current
0409-1391	Meropenem	Meropenem	Hospira, Inc.	ANDA	Current
0409-1391	Meropenem	Meropenem	Hospira, Inc.	ANDA	Current
0409-1391	Meropenem	Meropenem	Hospira, Inc.	ANDA	Current
0409-3412	Meropenem	Meropenem	Hospira, Inc.	ANDA	Current
63323-507	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-507	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-507	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-507	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-507	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-507	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-507	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-507	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-507	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-507	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-507	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-507	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-507	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-507	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-507	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-507	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-507	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-507	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-508	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-508	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-508	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-508	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-508	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-508	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-508	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-508	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-508	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-508	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-508	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-508	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-508	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-508	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-508	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-508	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-508	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current
63323-508	Meropenem	Meropenem	Fresenius Kabi USA, LLC	ANDA	Current