Application 050587

Type: NDA
Sponsor: MERCK

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N050587-001	PRIMAXIN	CILASTATIN SODIUM; IMIPENEM	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26
N050587-002	PRIMAXIN	CILASTATIN SODIUM; IMIPENEM	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050587-002	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 · 84 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
2026-08-18 06:07:40	2026-07	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		RLD	1985-11-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		RLD	1985-11-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		RLD	1985-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N050587-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050587-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050587-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050587-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050587-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050587-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050587-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050587-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050587-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050587-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050587-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050587-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050587-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050587-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050587-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050587-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050587-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050587-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050587-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050587-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050587-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050587-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050587-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050587-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050587-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050587-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050587-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050587-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050587-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050587-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050587-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050587-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050587-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050587-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050587-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050587-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050587-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050587-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050587-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050587-002	AP	1	`e64feba35796…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRIMAXIN IV	IMIPENEM AND CILASTATIN SODIUM	Merck Sharp & Dohme LLC	f41d8abd-7792-4918-1b93-bd83ea01955e	2024-07-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050587 application number: NDA050587 ndc (product): 0006-3516

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
0006-3516	PRIMAXIN	imipenem and cilastatin sodium	Merck Sharp & Dohme Corp.	NDA	Current
0006-3516	PRIMAXIN	imipenem and cilastatin sodium	Merck Sharp & Dohme Corp.	NDA	Current
0006-3516	PRIMAXIN	imipenem and cilastatin sodium	Merck Sharp & Dohme Corp.	NDA	Current
0006-3516	PRIMAXIN	imipenem and cilastatin sodium	Merck Sharp & Dohme Corp.	NDA	Current
0006-3516	PRIMAXIN	imipenem and cilastatin sodium	Merck Sharp & Dohme LLC	NDA	Current
0006-3516	PRIMAXIN	imipenem and cilastatin sodium	Merck Sharp & Dohme Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70052	SUPPL	2022-02-02
69999	SUPPL	2022-01-31
57691	ORIG	2019-02-15
56883	SUPPL	2018-12-21
56740	SUPPL	2018-12-14
46448	SUPPL	2016-12-21
46270	SUPPL	2016-12-20
17905	SUPPL	2014-12-17
7855	SUPPL	2014-12-17
7854	SUPPL	2012-04-18
39013	SUPPL	2012-04-16
30126	SUPPL	2009-11-20
39012	SUPPL	2009-09-22
7853	SUPPL	2008-12-19
42652	SUPPL	2008-08-11
22164	SUPPL	2008-08-01
30125	SUPPL	2008-04-02
39011	SUPPL	2008-04-01
42658	SUPPL	2008-02-19
42657	SUPPL	2008-02-19
42653	SUPPL	2008-02-19
42651	SUPPL	2008-02-19
22163	SUPPL	2008-02-19
42656	SUPPL	2007-11-19
42655	SUPPL	2007-11-19
42654	SUPPL	2007-11-19
30124	SUPPL	2006-08-07
7852	SUPPL	2004-05-26
30123	SUPPL	2003-03-10
7851	SUPPL	2001-11-30
39010	SUPPL	1998-04-08
7850	SUPPL	1998-04-08