Application 209448

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	10GM/100ML	No	No

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

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
A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	10GM/100ML	INJECTABLE / INJECTION	AP		2018-07-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209448-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209448-001	DEXTROSE 10% IN PLASTIC CONTAINER	10GM/100ML	INJECTABLE / INJECTION	AP	2018-07-16	`e64feba35796…`

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	A209448-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209448-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209448-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209448-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209448-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209448-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209448-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209448-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209448-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209448-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209448-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209448-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209448-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209448-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209448-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209448-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209448-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209448-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209448-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209448-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209448-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209448-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209448-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209448-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209448-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209448-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209448-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209448-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209448-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209448-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209448-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209448-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209448-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209448-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209448-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209448-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209448-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209448-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209448-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209448-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dextrose	DEXTROSE MONOHYDRATE	Becton Dickinson and Company	8e7046f8-841e-465a-af69-af9fb3d6799d	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209448 application number: ANDA209448 ndc (product): 17271-721
DEXTROSE	DEXTROSE	HF Acquisition Co. LLC. DBA HealthFirst	4d2d3d3d-d96e-4005-e063-6394a90afd9a	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209448 application number: ANDA209448
Dextrose	DEXTROSE MONOHYDRATE	Fresenius Kabi USA, LLC	3b8f2692-4371-4f1a-95af-b41842131fdd	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209448 application number: ANDA209448 ndc (product): 63323-824

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
17271-721	Dextrose	Dextrose Monohydrate	Becton Dickinson and Company	ANDA	Current
17271-721	Dextrose	Dextrose Monohydrate	Becton Dickinson and Company	ANDA	Current
17271-721	Dextrose	Dextrose Monohydrate	Becton Dickinson and Company	ANDA	Current
63323-824	Dextrose	Dextrose Monohydrate	Fresenius Kabi USA, LLC	ANDA	Current
63323-824	Dextrose	Dextrose Monohydrate	Fresenius Kabi USA, LLC	ANDA	Current
63323-824	Dextrose	Dextrose Monohydrate	Fresenius Kabi USA, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55186	ORIG	2018-08-16