Application 022106

Type: NDA
Sponsor: SHIONOGI INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DORIBAX	DORIPENEM	INJECTABLE;INTRAVENOUS	500MG/VIAL	Yes	No
002	DORIBAX	DORIPENEM	INJECTABLE;INTRAVENOUS	250MG/VIAL	Yes	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
N022106-001	DORIBAX	DORIPENEM	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2007-10-12
N022106-002	DORIBAX	DORIPENEM	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2010-10-05

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022106-001	DORIBAX	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2007-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022106-002	DORIBAX	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2010-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022106-001	DORIBAX	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2007-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022106-002	DORIBAX	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2010-10-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022106-001	DORIBAX	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2007-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022106-002	DORIBAX	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2010-10-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022106-001	DORIBAX	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2007-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022106-002	DORIBAX	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2010-10-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022106-001	DORIBAX	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2007-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022106-002	DORIBAX	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2010-10-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022106-001	DORIBAX	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2007-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022106-002	DORIBAX	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2010-10-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022106-001	DORIBAX	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2007-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022106-002	DORIBAX	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2010-10-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022106-001	DORIBAX	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2007-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022106-002	DORIBAX	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2010-10-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022106-001	DORIBAX	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2007-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022106-002	DORIBAX	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2010-10-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022106-001	DORIBAX	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2007-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022106-002	DORIBAX	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2010-10-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022106-001	DORIBAX	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2007-10-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022106-002	DORIBAX	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2010-10-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022106-001	DORIBAX	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2007-10-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022106-002	DORIBAX	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2010-10-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022106-001	DORIBAX	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2007-10-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022106-002	DORIBAX	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2010-10-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022106-001	DORIBAX	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2007-10-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022106-002	DORIBAX	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2010-10-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022106-001	DORIBAX	500MG/VIAL	INJECTABLE / INTRAVENOUS	RLD	2007-10-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022106-002	DORIBAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	RLD	2010-10-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022106-001	DORIBAX	500MG/VIAL	INJECTABLE / INTRAVENOUS	RLD	2007-10-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022106-002	DORIBAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	RLD	2010-10-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022106-001	DORIBAX	500MG/VIAL	INJECTABLE / INTRAVENOUS	RLD	2007-10-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022106-002	DORIBAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	RLD	2010-10-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022106-001	DORIBAX	500MG/VIAL	INJECTABLE / INTRAVENOUS	RLD	2007-10-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022106-002	DORIBAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	RLD	2010-10-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022106-001	DORIBAX	500MG/VIAL	INJECTABLE / INTRAVENOUS	RLD	2007-10-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022106-002	DORIBAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	RLD	2010-10-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022106-001	DORIBAX	500MG/VIAL	INJECTABLE / INTRAVENOUS	RLD	2007-10-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022106-002	DORIBAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	RLD	2010-10-05	`782e0a99824c…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022106-001	8247402	2021-03-30	Drug substance, Drug product	2012-09-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022106-002	8247402	2021-03-30	Drug substance, Drug product		`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022106-001	8247402	2021-03-30	Drug substance, Drug product	2012-09-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022106-002	8247402	2021-03-30	Drug substance, Drug product		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022106-001	8247402	2021-03-30	Drug substance, Drug product	2012-09-13	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022106-002	8247402	2021-03-30	Drug substance, Drug product		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022106-001	8247402	2021-03-30	Drug substance, Drug product	2012-09-13	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022106-002	8247402	2021-03-30	Drug substance, Drug product		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022106-001	8247402	2021-03-30	Drug substance, Drug product	2012-09-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022106-002	8247402	2021-03-30	Drug substance, Drug product		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022106-001	8247402	2021-03-30	Drug substance, Drug product	2012-09-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022106-002	8247402	2021-03-30	Drug substance, Drug product		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022106-001	8247402	2021-03-30	Drug substance, Drug product	2012-09-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022106-002	8247402	2021-03-30	Drug substance, Drug product		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022106-001	8247402	2021-03-30	Drug substance, Drug product	2012-09-13	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022106-002	8247402	2021-03-30	Drug substance, Drug product		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022106-001	8247402	2021-03-30	Drug substance, Drug product	2012-09-13	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022106-002	8247402	2021-03-30	Drug substance, Drug product		`ea99ee380514…`

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
59630-309	Doribax	doripenem	Shionogi Inc.	NDA	Current
59630-309	Doribax	doripenem	Shionogi Inc.	NDA	Current
59630-320	Doribax	doripenem	Shionogi Inc.	NDA	Current
59630-320	Doribax	doripenem	Shionogi Inc.	NDA	Current
60505-6160	DORIPENEM	DORIPENEM	Apotex Corp.	NDA	Current
60505-6161	DORIPENEM	DORIPENEM	Apotex Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
38250	SUPPL	2015-08-11
29254	SUPPL	2015-08-11
16944	SUPPL	2014-01-22
6891	SUPPL	2014-01-21
29253	SUPPL	2013-04-16
29252	SUPPL	2013-04-16
29251	SUPPL	2013-04-16
6890	SUPPL	2013-04-16
38249	SUPPL	2013-04-15
38248	SUPPL	2013-04-15
16945	SUPPL	2013-04-15
16942	SUPPL	2013-04-15
16943	SUPPL	2012-01-31
38246	SUPPL	2009-04-23
16941	SUPPL	2009-04-23
29250	SUPPL	2009-04-21
6889	SUPPL	2009-04-21
38247	SUPPL	2009-02-12
24241	ORIG	2008-07-22
42415	ORIG	2008-03-14
6888	ORIG	2007-10-22
16940	ORIG	2007-10-15