Application 019445

Type: NDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROSE 50% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	500MG/ML	Yes	No
002	DEXTROSE 25%	DEXTROSE	INJECTABLE;INJECTION	250MG/ML	Yes	Yes
003	DEXTROSE 50%	DEXTROSE	INJECTABLE;INJECTION	500MG/ML	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
N019445-001	DEXTROSE 50%	DEXTROSE	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03
N019445-002	DEXTROSE 25%	DEXTROSE	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019445-001	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 3 · 90 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	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019445-001	DEXTROSE 50% IN PLASTIC CONTAINER	500MG/ML	INJECTABLE / INJECTION		RLD	1986-06-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019445-003	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION		RLD	2014-09-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019445-002	DEXTROSE 25%	250MG/ML	INJECTABLE / INJECTION		RLD, RS	1998-11-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019445-001	DEXTROSE 50%	500MG/ML	INJECTABLE / INJECTION	AP	RLD	1986-06-03	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019445-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019445-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019445-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019445-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019445-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019445-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019445-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019445-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019445-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019445-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019445-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019445-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019445-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019445-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019445-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019445-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019445-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N019445-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019445-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019445-001	AP	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019445-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019445-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019445-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019445-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019445-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019445-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019445-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019445-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019445-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019445-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019445-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019445-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019445-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019445-001	AP	1	`a50c72e98297…`

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	4ed365da-4e62-4329-c1b9-c197ab4fb6e1	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445 ndc (product): 0409-6648 ndc (product): 0409-7517
Infant Dextrose	DEXTROSE	Henry Schein, Inc.	ce71d929-d11e-444c-bd45-e025d5172057	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445 ndc (product): 0404-9844
Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	672264e3-9709-4bba-2a9d-12bf70c7396a	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445 ndc (product): 0409-1775
Dextrose	DEXTROSE MONOHYDRATE	Henry Schein, Inc.	40fd1ac4-39bb-45fb-ba99-4fb65481f231	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445 ndc (product): 0404-9847
Dextrose	DEXTROSE MONOHYDRATE	Henry Schein, Inc.	8cf6943f-16e8-4521-863c-09bb0b55e2a9	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445 ndc (product): 0404-9845
Dextrose	DEXTROSE MONOHYDRATE	REMEDYREPACK INC.	b8b77421-d687-45aa-82f6-d49bce644c10	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445
Dextrose	DEXTROSE MONOHYDRATE	REMEDYREPACK INC.	e2638b45-1141-4391-971d-c0dea825e41c	2025-08-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445
Dextrose	DEXTROSE MONOHYDRATE	ProPharma Distribution	3842a9c0-8b15-1c94-e063-6394a90ae120	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445
50% DEXTROSE	50% DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	763b1cb8-1151-5f59-e053-2991aa0a4e01	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445 ndc (product): 51662-1216
DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	75c902e8-50e7-a337-e053-2991aa0a2093	2024-02-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445 ndc (product): 51662-1215
Dextrose	DEXTROSE MONOHYDRATE	Medical Purchasing Solutions, LLC	677a81e5-26ba-2a69-e053-2991aa0a101a	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445 ndc (product): 71872-7057
Dextrose	DEXTROSE MONOHYDRATE	Medical Purchasing Solutions, LLC	ada63d44-3b37-b65d-e053-2a95a90aa088	2023-05-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445 ndc (product): 71872-7214
25% Dextrose Infant	25% DEXTROSE INFANT	HF Acquisition Co. LLC, DBA Health First	73d04839-a2bb-65dd-e053-2991aa0a82ca	2022-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445 ndc (product): 51662-1213
Dextrose	DEXTROSE MONOHYDRATE	Medical Purchasing Solutions, LLC	66713d9c-f404-4ec8-e053-2a91aa0a620a	2022-10-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019445 application number: NDA019445 ndc (product): 71872-7003

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 64 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9844	Infant Dextrose	Dextrose	Henry Schein, Inc.	NDA	Current
0404-9844	Infant Dextrose	Dextrose	Henry Schein, Inc.	NDA	Current
0404-9844	Infant Dextrose	Dextrose	Henry Schein, Inc.	NDA	Current
0404-9845	Dextrose	Dextrose Monohydrate	Henry Schein, Inc.	NDA	Current
0404-9845	Dextrose	Dextrose Monohydrate	Henry Schein, Inc.	NDA	Current
0404-9847	Dextrose	Dextrose Monohydrate	Henry Schein, Inc.	NDA	Current
0404-9847	Dextrose	Dextrose Monohydrate	Henry Schein, Inc.	NDA	Current
0409-1775	Dextrose	Dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-1775	Dextrose	Dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-1775	Dextrose	Dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-1775	Dextrose	Dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-1775	Dextrose	Dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-1775	Dextrose	Dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-6648	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-6648	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-6648	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-6648	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-6648	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-6648	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-7517	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-7517	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-7517	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-7517	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-7517	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-7517	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
50090-2942	Dextrose	DEXTROSE MONOHYDRATE	A-S Medication Solutions	NDA	Current
51662-1213	25% Dextrose Infant	25% Dextrose Infant	HF Acquisition Co. LLC, DBA Health First	NDA	Current
51662-1213	25% Dextrose Infant	25% Dextrose Infant	HF Acquisition Co. LLC, DBA Health First	NDA	Current
51662-1213	25% Dextrose Infant	25% Dextrose Infant	HF Acquisition Co. LLC, DBA Health First	NDA	Current
51662-1213	25% Dextrose Infant	25% Dextrose Infant	HF Acquisition Co. LLC, DBA Health First	NDA	Current
51662-1215	DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1215	DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1215	DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1215	DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1216	50% DEXTROSE	50% DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1216	50% DEXTROSE	50% DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1216	50% DEXTROSE	50% DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1216	50% DEXTROSE	50% DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52584-517	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-517	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-517	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-517	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-517	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-517	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-517	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-517	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-648	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-648	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-648	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-775	Infant Dextrose	Dextrose	General Injectables & Vaccines, Inc	NDA	Current
52584-775	Infant Dextrose	Dextrose	General Injectables & Vaccines, Inc	NDA	Current
52584-775	Infant Dextrose	Dextrose	General Injectables & Vaccines, Inc	NDA	Current
52584-775	Infant Dextrose	Dextrose	General Injectables & Vaccines, Inc	NDA	Current
52584-775	Infant Dextrose	Dextrose	General Injectables & Vaccines, Inc	NDA	Current
52584-775	Infant Dextrose	Dextrose	General Injectables & Vaccines, Inc	NDA	Current
55154-6977	Dextrose	DEXTROSE MONOHYDRATE	Cardinal Health	NDA	Current
55154-6977	Dextrose	DEXTROSE MONOHYDRATE	Cardinal Health	NDA	Current
70518-1427	Dextrose	DEXTROSE MONOHYDRATE	REMEDYREPACK INC.	NDA	Current
71872-7003	Dextrose	DEXTROSE MONOHYDRATE	Medical Purchasing Solutions, LLC	NDA	Current
71872-7003	Dextrose	DEXTROSE MONOHYDRATE	Medical Purchasing Solutions, LLC	NDA	Current
71872-7003	Dextrose	DEXTROSE MONOHYDRATE	Medical Purchasing Solutions, LLC	NDA	Current
71872-7057	Dextrose	DEXTROSE MONOHYDRATE	Medical Purchasing Solutions, LLC	NDA	Current
71872-7057	Dextrose	DEXTROSE MONOHYDRATE	Medical Purchasing Solutions, LLC	NDA	Current
71872-7214	Dextrose	Dextrose monohydrate	Medical Purchasing Solutions, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82964	SUPPL	2025-07-28
82963	SUPPL	2025-07-28
82953	SUPPL	2025-07-28
82952	SUPPL	2025-07-28
20242	SUPPL	1998-11-23
20241	SUPPL	1998-11-23
17406	SUPPL	1998-11-23
1325	SUPPL	1998-11-23