Application 090825

Type: ANDA
Sponsor: HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMIPENEM AND CILASTATIN	CILASTATIN SODIUM; IMIPENEM	POWDER;INTRAVENOUS	EQ 250MG BASE/VIAL;250MG/VIAL	No	No
002	IMIPENEM AND CILASTATIN	CILASTATIN SODIUM; IMIPENEM	POWDER;INTRAVENOUS	EQ 500MG BASE/VIAL;500MG/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A090825-001	IMIPENEM AND CILASTATIN	CILASTATIN SODIUM; IMIPENEM	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS			2011-11-16
A090825-002	IMIPENEM AND CILASTATIN	CILASTATIN SODIUM; IMIPENEM	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS			2011-11-16

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 2 of 3 · 88 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
2019-12-13 00:20 UTC	2019-12	A090825-001	IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS	AP	2011-11-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090825-002	IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090825-001	IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090825-002	IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090825-001	IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090825-002	IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090825-001	IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090825-002	IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090825-001	IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090825-002	IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090825-001	IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090825-002	IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090825-001	IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090825-002	IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090825-001	IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS	AP	2011-11-16	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090825-002	IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090825-001	IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090825-002	IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	2011-11-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090825-001	IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090825-002	IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	2011-11-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090825-001	IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090825-002	IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090825-001	IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090825-002	IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090825-001	IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A090825-002	IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090825-001	IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090825-002	IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090825-001	IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090825-002	IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090825-001	IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090825-002	IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090825-001	IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090825-002	IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090825-001	IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A090825-002	IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090825-001	IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A090825-002	IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090825-001	IMIPENEM AND CILASTATIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090825-002	IMIPENEM AND CILASTATIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS		2011-11-16	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090825-001	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A090825-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090825-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090825-002	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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Imipenem and Cilastatin	IMIPENEM AND CILASTATIN	WG Critical Care, LLC	46f54df9-5afe-430c-aa19-0d84c2044b0b	2025-01-16	Warnings, Adverse reactions	Name fallback brand name: Imipenem and Cilastatin
Imipenem and Cilastatin	IMIPENEM AND CILASTATIN SODIUM	Fresenius Kabi USA, LLC	ce771566-c4f2-447e-944a-6b908925c90b	2022-10-11	Warnings, Adverse reactions	Name fallback brand name: Imipenem and Cilastatin
Imipenem and Cilastatin	IMIPENEM AND CILASTATIN SODIUM	Fresenius Kabi USA, LLC	0a1dd9b9-ada1-4bff-9dcb-18961254e9e8	2022-10-10	Warnings, Adverse reactions	Name fallback brand name: Imipenem and Cilastatin
Imipenem and Cilastatin	IMIPENEM AND CILASTATIN SODIUM	Fresenius Kabi USA, LLC	6ab0ca9e-9a79-4cab-9f09-470eda06952e	2022-10-06	Warnings, Adverse reactions	Name fallback brand name: Imipenem and Cilastatin

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-3507	Imipenem and Cilastatin	Imipenem and Cilastatin	Hospira, Inc.	ANDA	Current
0409-3508	Imipenem and Cilastatin	Imipenem and Cilastatin	Hospira, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31501	ORIG	2011-11-21