Application 021337

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INVANZ	ERTAPENEM SODIUM	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 1GM BASE/VIAL	Yes	Yes

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
N021337-001	INVANZ	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021337-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021337-001	INVANZ	EQ 1GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2001-11-21	`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	N021337-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021337-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021337-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021337-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021337-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021337-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021337-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021337-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021337-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021337-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021337-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021337-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021337-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021337-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021337-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021337-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021337-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021337-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021337-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021337-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021337-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021337-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021337-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021337-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021337-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021337-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021337-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021337-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021337-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021337-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021337-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021337-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021337-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021337-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021337-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021337-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021337-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021337-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021337-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021337-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ERTAPENEM	ERTAPENEM SODIUM	ENDO USA, Inc.	41304b1d-7db4-468a-ab1d-04e56fb50de4	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021337 application number: NDA021337 ndc (product): 42023-221
ERTAPENEM	ERTAPENEM SODIUM	ENDO USA, Inc.	657855f2-7c92-4aa8-9c3d-51d08e56a09a	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021337 application number: NDA021337 ndc (product): 42023-221
INVANZ	ERTAPENEM SODIUM	Merck Sharp & Dohme LLC	33f3b99b-fa82-42e0-26bf-f49891ae3d22	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021337 application number: NDA021337 ndc (product): 0006-3843

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-3843	INVANZ	ertapenem sodium	Merck Sharp & Dohme Corp.	NDA	Current
0006-3843	INVANZ	ertapenem sodium	Merck Sharp & Dohme Corp.	NDA	Current
0006-3843	INVANZ	ertapenem sodium	Merck Sharp & Dohme LLC	NDA	Current
0006-3843	INVANZ	ertapenem sodium	Merck Sharp & Dohme Corp.	NDA	Current
0006-3843	INVANZ	ertapenem sodium	Merck Sharp & Dohme Corp.	NDA	Current
0006-3843	INVANZ	ertapenem sodium	Merck Sharp & Dohme Corp.	NDA	Current
0006-3843	INVANZ	ertapenem sodium	Merck Sharp & Dohme Corp.	NDA	Current
42023-221	ERTAPENEM	ertapenem sodium	Par Pharmaceutical Inc.	NDA	Current
42023-221	ERTAPENEM	ertapenem sodium	Par Pharmaceutical Inc.	NDA	Current
42023-221	ERTAPENEM	ertapenem sodium	Par Pharmaceutical Inc.	NDA	Current
42023-221	ERTAPENEM	ertapenem sodium	Par Pharmaceutical Inc.	NDA	Current
42023-221	ERTAPENEM	ertapenem sodium	Par Pharmaceutical Inc.	NDA	Current
42023-221	ERTAPENEM	ertapenem sodium	Par Pharmaceutical Inc.	NDA	Current
42023-221	ERTAPENEM	ertapenem sodium	Par Pharmaceutical Inc.	NDA	Current
42023-221	ERTAPENEM	ertapenem sodium	Par Pharmaceutical Inc.	NDA	Current
42023-221	ERTAPENEM	ertapenem sodium	Par Pharmaceutical Inc.	NDA	Current
42023-221	ERTAPENEM	ertapenem sodium	Par Pharmaceutical Inc.	NDA	Current
42023-221	ERTAPENEM	ertapenem sodium	Par Pharmaceutical Inc.	NDA	Current
42023-221	ERTAPENEM	ertapenem sodium	Par Pharmaceutical Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70564	SUPPL	2022-03-21
70555	SUPPL	2022-03-18
65754	SUPPL	2020-12-28
65714	SUPPL	2020-12-23
60172	SUPPL	2019-10-01
60089	SUPPL	2019-09-23
56939	SUPPL	2018-12-21
56895	SUPPL	2018-12-20
55524	SUPPL	2018-09-19
55480	SUPPL	2018-09-14
49809	SUPPL	2017-09-20
49727	SUPPL	2017-09-13
15216	SUPPL	2014-10-02
5081	SUPPL	2014-10-02
42107	SUPPL	2014-01-16
36689	SUPPL	2013-07-30
27515	SUPPL	2013-07-26
15215	SUPPL	2012-03-07
5080	SUPPL	2012-03-05
15214	SUPPL	2012-02-22
15211	SUPPL	2011-07-25
5078	SUPPL	2011-07-25
15213	SUPPL	2010-05-28
27514	SUPPL	2010-05-27
5077	SUPPL	2010-01-25
36688	SUPPL	2009-12-15
5079	SUPPL	2009-11-10
15212	SUPPL	2009-10-14
36687	SUPPL	2008-03-27
5076	SUPPL	2008-03-26
5075	SUPPL	2007-11-19
5074	SUPPL	2006-08-14
36686	SUPPL	2006-08-11
36685	SUPPL	2005-10-19
27513	SUPPL	2005-10-19
36684	SUPPL	2005-05-20
5073	SUPPL	2005-05-20
27512	SUPPL	2005-01-26
27511	SUPPL	2004-09-10
5072	SUPPL	2004-05-26
27510	SUPPL	2004-05-04
36683	ORIG	2001-11-09
21608	ORIG	2001-11-09
5071	ORIG	2001-11-09
51850	ORIG	1900-01-01
51849	ORIG	1900-01-01
51848	ORIG	1900-01-01
51847	ORIG	1900-01-01