Application 021321

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EXTRANEAL	ICODEXTRIN	SOLUTION;INTRAPERITONEAL	7.5GM/100ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N021321-001	EXTRANEAL	ICODEXTRIN	7.5GM/100ML	SOLUTION / INTRAPERITONEAL		RLD, RS	2002-12-20

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021321-001	EXTRANEAL	7.5GM/100ML	SOLUTION / INTRAPERITONEAL	RLD, RS	2002-12-20	`f41ea6bd6efb…`

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
EXTRANEAL	ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE	Vantive US Healthcare LLC	d5b85158-b0d6-4855-9d07-8d1b3ad9ab71	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021321 application number: NDA021321 ndc (product): 0941-0679

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0941-0679	EXTRANEAL	icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride	Baxter Healthcare Corporation	NDA	Current
0941-0679	EXTRANEAL	icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride	Baxter Healthcare Corporation	NDA	Current
0941-0679	EXTRANEAL	icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride	Baxter Healthcare Corporation	NDA	Current
0941-0679	EXTRANEAL	icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride	Baxter Healthcare Corporation	NDA	Current
0941-0679	EXTRANEAL	icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride	Baxter Healthcare Corporation	NDA	Current
0941-0679	EXTRANEAL	icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78250	SUPPL	2024-04-25
78207	SUPPL	2024-04-23
61180	SUPPL	2019-12-06
61169	SUPPL	2019-12-06
46470	SUPPL	2016-12-22
46230	SUPPL	2016-12-20
45638	SUPPL	2016-10-25
15189	SUPPL	2015-10-22
5035	SUPPL	2015-10-21
5033	SUPPL	2014-12-11
5034	SUPPL	2014-02-27
23994	ORIG	2011-03-25
36653	SUPPL	2011-03-11
15188	SUPPL	2011-03-11
27477	SUPPL	2011-03-10
5032	SUPPL	2011-03-10
23254	ORIG	2009-11-18
36652	SUPPL	2009-04-16
5030	SUPPL	2009-04-15
5031	SUPPL	2009-02-03
5029	SUPPL	2007-03-06
5027	SUPPL	2005-05-25
5026	SUPPL	2005-05-25
36651	SUPPL	2004-12-30
5028	SUPPL	2004-12-30
27476	ORIG	2004-06-03
42099	ORIG	2003-04-25
15187	ORIG	2003-04-09